Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta

P220007 · Alcon Laboratories, Inc. · LPM · Apr 25, 2023 · Ophthalmic

Device Facts

Record IDP220007
Device NamePrecision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta
ApplicantAlcon Laboratories, Inc.
Product CodeLPM · Ophthalmic
Decision DateApr 25, 2023
DecisionAPPR
Regulation21 CFR 886.5925
Device ClassClass 3

Indications for Use

Precision7™ (serafilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic and aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. Precision7™ for Astigmatism (serafilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have up to 6.00 diopters (D) of astigmatism. Precision7™ Multifocal (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. Precision7™ Multifocal Toric (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism. The lenses are to be prescribed for extended wear for up to 6 continuous nights with removal for disposal, or cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each week, or more often, if recommended by the eye care professional.

Device Story

Precision7™ soft contact lenses are serafilcon A (55% water) lenses designed for extended wear (up to 6 nights). Lenses act as a refracting medium on the cornea to focus light on the retina. They are tinted with Reactive Blue 247 and contain benzotriazole monomers for UVA/UVB protection. Prescribed by eye care professionals for patients with refractive ametropia or presbyopia. Patients wear lenses continuously for up to 6 nights, then remove for disposal or cleaning/disinfection. Weekly replacement schedule. Output is corrected vision. Benefits include vision correction and convenience of overnight wear. Risks include ocular infection, inflammation, and other complications typical of extended wear lenses.

Clinical Evidence

Prospective, multi-center, randomized, double-blinded 12-month clinical study (IDE G190046) with 581 enrolled dispensed subjects (1162 eyes). Primary safety endpoint: proportion of ocular serious and significant non-serious adverse device effects (ADEs). Non-inferiority to comfilcon A control met (margin 0.05). Test group: 0% serious ADEs, 1.0% significant non-serious ADEs. Effectiveness: 99.9% of eyes achieved ≥20/25 visual acuity. Supplemental studies confirmed safety for 1-night and 6-night extended wear.

Technological Characteristics

Material: 55% water, 45% serafilcon A (amphiphilic copolymer). Tint: Reactive Blue 247 (21 CFR 73.3100). UV blockers: benzotriazole monomers. Oxygen permeability: 119 ± 24 barrer. Refractive index: 1.402. Sterilization: Moist heat (autoclave, SAL 10^-6). Standards: ISO 10993-5, -10, -11, -3; ISO 9394; ISO 18189; ISO 18369-2.

Indications for Use

Indicated for phakic/aphakic persons with non-diseased eyes requiring optical correction of refractive ametropia (myopia/hyperopia) and/or presbyopia, with up to 6.00D astigmatism and/or +3.00D reading addition. Contraindicated in patients with anterior chamber inflammation/infection, active corneal/conjunctival/eyelid disease, microbial infection, dry eye, corneal hypoesthesia, or systemic diseases interfering with lens wear.

Regulatory Classification

Identification

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0} SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. GENERAL INFORMATION Device Generic Name: serafilcon A soft contact lens Device Trade Name: Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Contact Lenses Device Procode: LPM Applicant’s Name and Address: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099, USA Date(s) of Panel Recommendation: None Premarket Approval Application (PMA) Number: P220007 Date of FDA Notice of Approval: April 25, 2023 II. INDICATIONS FOR USE Precision7™ (serafilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic and aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. Precision7™ for Astigmatism (serafilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have up to 6.00 diopters (D) of astigmatism. Precision7™ Multifocal (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. Precision7™ Multifocal Toric (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a PMA P220007: FDA Summary of Safety and Effectiveness Data {1} reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism. The lenses are to be prescribed for extended wear for up to 6 continuous nights with removal for disposal, or cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each week, or more often, if recommended by the eye care professional. ## III. CONTRAINDICATIONS Do not use serafilcon A contact lenses when any of the following exists: - Inflammation or infection of the anterior chamber of the eye - Active disease, injury or abnormality affecting the cornea, conjunctiva, or eyelids - Microbial infection of the eye - Insufficiency of lacrimal secretion (dry eye) that interferes with contact lens wear - Corneal hypoesthesia (reduced corneal sensitivity) - Use of any medication that is contraindicated or interferes with contact lens wear, including eye medications - Any systemic disease that may be exacerbated by or interferes with contact lens wear - Allergic reactions or irritation of the ocular surfaces or adnexa that may be caused by or exacerbated by the wearing of contact lenses - Patient history of recurring eye or eyelid infections, adverse effects associated with contact lens wear, intolerance or abnormal ocular response to contact lens wear - If eyes become red or irritated ## IV. WARNINGS AND PRECAUTIONS The warnings and precautions can be found in the Precision7™, Precision7™ for Astigmatism, Precision7™ Multifocal, Precision7™ Multifocal Toric (serafilcon A) Soft Contact Lenses labeling. ## V. DEVICE DESCRIPTION ![img-0.jpeg](img-0.jpeg) Figure 1. Photo of Precision7™ (serafilcon A) soft contact lens (not to scale, contains reflections) PMA P220007: FDA Summary of Safety and Effectiveness Data {2} Precision7™, Precision7™ for Astigmatism, Precision7™ Multifocal, Precision7™ Multifocal Toric (serafilcon A) Soft Contact Lenses are composed of 55% water and 45% serafilcon A material. The serafilcon A material is an amphiphilic copolymer of silicone containing monomer, silicone containing macromer, hydrophilic monomers, and a cross linker. The lenses are tinted for visibility with Reactive Blue 247, a color additive that conforms to 21 CFR 73.3100. In addition, lenses contain two benzotriazole monomers to block UVA and UVB radiation, and additionally, reduce transmittance in the range of 380 nm to 450 nm. In its hydrated state, the Precision7™, Precision7™ for Astigmatism, Precision7™ Multifocal, Precision7™ Multifocal Toric (serafilcon A) Soft Contact Lenses, when placed on the cornea, act as a refracting medium to focus light rays on the retina. ## LENS PARAMETERS The lens designs include spherical, toric, multifocal, and multifocal toric lenses in the following parameter ranges: | Diameter | 13.0mm to 15.0mm | | --- | --- | | Center Thickness | 0.08mm @ -3.00 D (varies with power) | | Base Curve | 8.0mm to 9.2mm | | Power Range | +20.00D to -20.00D | | Cylinder Power (Toric) | -0.25D to -10.00D | | Cylinder Axis (Toric) | 001 to 180° | | Add Power (Multifocal) | LO, MED, HI | The Precision7™, Precision7™ for Astigmatism, Precision7™ Multifocal, Precision7™ Multifocal Toric (serafilcon A) Soft Contact Lenses have the following physical properties: | Refractive Index: | 1.402 | | --- | --- | | Light Transmittance: | ≥ 90% (@ 640 nm, -3.00 D) | | Water Content: | 55% by weight in normal saline | | Oxygen Permeability: | 119 ± 24 barrer @ 35°C (polarographic method) | | UV Transmittance: | The transmittance characteristics are less than 1% in the UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 316 to 380 nm for the entire power range. | ## VI. ALTERNATIVE PRACTICES AND PROCEDURES There are several other alternatives for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes. The currently available alternate practices and procedures for vision correction are commercially available daily disposable contact lenses, commercially available daily wear contact lenses, other commercially available contact lenses approved for extended wear, spectacles, refractive keratoplasty, laser-assisted in-situ keratomileusis PMA P220007: FDA Summary of Safety and Effectiveness Data {3} (LASIK), and corneal implants. Each alternative has its own advantages and disadvantages. A patient should fully discuss these alternatives with his/her physician to select the method that best meets expectations and lifestyle. ## VII. MARKETING HISTORY Since December 28, 2021, Alcon Laboratories, Inc. has held US marketing clearance for (serafilcon A) soft contact lenses for daily wear under 510(k) K212806. Summary information about these lenses (Alcon™, Alcon™ for Astigmatism, Alcon™ Multifocal, Alcon™ Multifocal Toric (serafilcon A) soft contact lens) is available on the FDA website at: http://www.accessdata.fda.gov/cdrh_docs/pdf21/K212806.pdf. The lenses cleared under K212806 have not been marketed in the US or any foreign country. ## VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH Below is a list of the potential adverse effects (e.g., complications) associated with the use of the device. - Moderate to severe eye pain not relieved by removing the lens - Foreign body sensation - Excessive watering or other eye secretions including mucopurulent discharge - Redness of the eyes - Photophobia (light sensitivity) - Burning, stinging or itching, or other pain associated with the eyes - Poor visual acuity (reduced sharpness of vision) - Blurred vision, rainbows or halos around objects - Feeling of dryness For the specific adverse events that occurred in the clinical study, please see Section X below. ## IX. SUMMARY OF NONCLINICAL STUDIES ### A. Laboratory Studies #### 1. Biocompatibility Non-clinical biocompatibility testing was conducted in accordance with FDA’s Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994 and GLP regulation (21 CFR part 58) and applicable standards. The Applicant also determined that given the cumulative exposure from repeated use of the extended wear contact lenses, the permanent/long-term patient contact categorization would apply. Therefore, the Applicant performed a number of in PMA P220007: FDA Summary of Safety and Effectiveness Data {4} vitro and in vivo biocompatibility studies to support the safety of the subject final finished sterilized device serafilcon A contact lenses considering this permanent/long-term patient contact categorization. Endpoints addressed according to the May 1994 Guidance referenced above include cytotoxicity, acute ocular irritation, guinea pig maximization skin sensitization, acute systemic toxicity, and -ocular irritation due to repeated wear of contact lenses (rabbit contact lens wear studies). In addition, the Applicant elected to perform additional endpoint testing not specified in the May 1994 Guidance, including genotoxicity testing (bacterial and chromosomal), as well as performing cytotoxicity testing by multiple different test methods to evaluate the lenses or lens extracts. In addition, the Applicant performed several different rabbit contact lens wear studies with different contact lens care products used for cleaning/disinfection, as well as different lens wearing paradigms, considering that the subject device is an extended wear contact lens. The Applicant performed biocompatibility testing on the final finished sterilized contact lens and the primary packaging solution itself. The Applicant also provided sufficient information/justification to support that historical biocompatibility testing on primary packaging (blister shell and foil lidding) would be applicable to the subject device, since the subject device uses the same primary packaging that is also used by the referenced US marketed Alcon soft contact lenses. The non-clinical testing performed includes the following referenced biocompatibility standards: ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, ISO 9394:2012, ISO 18189:2016, ISO 10993-3:2014. ## All test results met the pre-established acceptance criteria. The testing performed on the Precision7™ (serafilcon A) extended wear soft contact lenses demonstrates that the lens is safe. PMA P220007: FDA Summary of Safety and Effectiveness Data 5 of 53 {5} Table 1: Biocompatibility - Contact Lens | Test | Purpose | Acceptance Criteria | Results | | --- | --- | --- | --- | | Cytotoxicity-Elution Method | Evaluates cellular toxicity potential of serum supplemented media-contact lens extract on cultured cells. | Non-cytotoxic | Pass | | Cytotoxicity-Direct Contact | Evaluates the cellular toxicity potential of the contact lens through direct placement of contact lens on cultured cell layer | Non-cytotoxic | Pass | | Cytotoxicity-Cell Growth Inhibition | Evaluates the potential for serum supplemented media-contact lens extract to impair cell growth | Non-cytotoxic | Pass | | Cytotoxicity-contact lens in combination with contact lens care solution | Evaluates the cellular toxicity potential, considering interactions between the contact lens used in combination with the evaluated lens care product solution | Non-cytotoxic | Pass | | Acute ocular irritation | Evaluates the potential of a single exposure to polar or non-polar contact lens extracts to cause acute eye irritation in rabbits | Not irritating to the eyes of New Zealand White rabbits through 72 hours after instillation | Pass | | 28 Day Contact Lens Wear using CLEARCARE® | Evaluates the potential of contact lenses to cause eye irritation in rabbits when worn daily for 28 days. 6 New Zealand White rabbits were used. Control lenses were CooperVision Biofinity® (comfilcon A), worn in the opposite eye. Test and control contact lenses were worn for 8 hours a day. New lenses (directly from final finished packaging) were used on days 1, 8, 15, and 22. On | No trends of worsening ocular irritation response. No slit lamp findings on day 1, 8, 15, 21, and 28. Conjunctival congestion was observed at similar sporadic levels in test and control eyes and did not show any trends of worsening over time. Histological results did not raise concerns. Restraint harness was used during the first few days of the study only and animals were | Pass | PMA P220007: FDA Summary of Safety and Effectiveness Data {6} PMA P220007: FDA Summary of Safety and Effectiveness Data 7 of 53 | | other study days, CLEAR CARE® was used for daily cleaning/disinfection of the lenses. | acclimated to the use of restraint harness prior to study start. Lens retention, which was checked every hour, was high (≥ 95%) for both test and control lenses. | | | --- | --- | --- | --- | | 28 Day Contact Lens Wear using Opti-Free® Replenish® | Evaluates the potential of contact lenses to cause eye irritation in rabbits when worn daily for 28 days. 6 New Zealand White rabbits were used. Control lenses were CooperVision Biofinity® (comfilcon A), worn in the opposite eye. Test and control contact lenses were worn for 8 hours a day. New lenses (directly from final finished packaging) were used on days 1, 8, 15, and 22. On other study days, Opti-Free® Replenish® was used for cleaning/disinfection of the lenses. | No trends of worsening ocular irritation response. No slit lamp findings on day 1, 8, 15, 21, and 28. Conjunctival congestion and conjunctival discharge was observed at similar sporadic levels in test and control eyes and did not show any trends of worsening over time. Histological results did not raise concerns. Restraint harness was used for the majority of the study days, and animals were acclimated to the use of restraint harness prior to study start. Overall, lens retention, which was checked every hour, was ≥88% for test and control lenses. | Pass | | 7-Day ‘Closed Eye’ Contact Lens Wear | Evaluates the potential of contact lenses to cause eye irritation in rabbits when worn daily for 7 days using a ‘closed-eye’ model. 6 New Zealand White rabbits were used. Control lenses were CooperVision Biofinity® (comfilcon A), worn in the opposite eye. Test and control lenses were worn for 8 hours a day for the 7 day study period. Each | Slit lamp exams performed at pre-screen, 1 day, 3 days, and 7 days did not raise concerns. Scores for conjunctival congestion were minimal to moderate, seen in both test and control eyes, and therefore not specific to the test article lens. Conjunctival discharge scores were none to minimal that was considered a general | Pass | {7} PMA P220007: FDA Summary of Safety and Effectiveness Data 8 of 53 | | day, new lenses were taken from the final finished packaging. Restraint devices were used throughout the study. After contact lens insertion, eyes were gently closed and a specific procedure was used to physically maintain eye closure for 8 hours each day. | response to contact lens wear and not specific to the test article lens. There were no trends toward worsening ocular irritation results over the course of the study. Histology was not performed as part of this study. | | | --- | --- | --- | --- | | Acute systemic injection | Evaluates the systemic toxicity potential of the contact lens extracts (polar and non-polar) in mice | Not systemically toxic based on daily weight measurements and observation for adverse clinical signs over 72 hours after administration. | Pass | | Guinea pig maximization | Evaluates the potential of the contact lens extracts (polar and non-polar) to cause skin sensitization. | Does not cause a skin sensitization response in Hartley guinea pigs. Historical positive control and concurrent negative control yielded expected results. | Pass | | Genotoxicity-Bacterial Reverse Mutation | Evaluates mutagenic potential of the contact lens extracts | Non-mutagenic | Pass | | Genotoxicity-Chromosome Aberration | Evaluates the clastogenic (large scale genetic damage) potential of the contact lens extracts | Non-genotoxic | Pass | {8} Table 2: Biocompatibility - Primary Packaging Solution | Test | Purpose | Acceptance Criteria | Results | | --- | --- | --- | --- | | Cytotoxicity-Modified Elution Method | Evaluates cellular toxicity potential of the neat packaging solution (combined with serum supplemented media) on cultured cells. | Non-cytotoxic | Pass | | Acute ocular irritation | Evaluates the potential of a single exposure to neat packaging solution to cause acute eye irritation in rabbits. | Not irritating to the eyes of New Zealand White rabbits through 72 hours after instillation | Pass | | Guinea pig maximization | Evaluates the potential of the neat primary packaging solution to cause skin sensitization. | Does not cause a skin sensitization response in Hartley guinea pigs. | Pass | | Genotoxicity-Bacterial Reverse Mutation | Evaluates mutagenic potential of the primary packaging solution | Non-mutagenic | Pass | | Genotoxicity-Chromosome Aberration | Evaluates the clastogenic (large scale genetic damage) potential of the primary packaging solution | Non-genotoxic | Pass | Table 3: Biocompatibility- Primary Packaging (Blister Shell/Foil Lidding) | Test | Purpose | Acceptance Criteria | Results | | --- | --- | --- | --- | | Cytotoxicity-Elution Method | Evaluates cellular toxicity potential of serum supplemented media-blister shell extract on cultured cells. | Non-cytotoxic | Pass | | Cytotoxicity-Elution Method | Evaluates cellular toxicity potential of serum supplemented media-foil lidding extract on cultured cells. | Non-cytotoxic | Pass | | Cytotoxicity- Direct Contact | Evaluates the cellular toxicity potential of foil lidding through direct placement of the lidding on cultured cell layer | Non-cytotoxic | Pass | PMA P220007: FDA Summary of Safety and Effectiveness Data {9} | Cytotoxicity-Cell Growth Inhibition | Evaluates the potential for serum supplemented media-blister shell extract to impair cell growth | Non-cytoxic | Pass | | --- | --- | --- | --- | | Acute ocular irritation | Evaluates the potential of a single exposure to blister shell extracts (polar and non-polar) to cause acute eye irritation in rabbits | Not irritating to the eyes of rabbits through 72 hours after instillation | Pass | | Acute ocular irritation | Evaluates the potential of a single exposure to foil lidding extracts (polar and non-polar) to cause acute eye irritation in rabbits | Not irritating to the eyes of rabbits through 72 hours after instillation | Pass | | Acute systemic injection | Evaluates the systemic toxicity potential of blister shell extracts (polar and non-polar) in mice | No biologically significant weight loss or adverse clinical/behavioral signs through 72 hours after extract administration | Pass | | Acute systemic injection | Evaluates the systemic toxicity potential of foil lidding extracts (polar and non-polar) in mice | No biologically significant weight loss or adverse clinical/behavioral signs through 72 hours after extract administration | Pass | 2. Physicochemical Tests Physicochemical tests were performed to demonstrate long term safety and stability of the properties of the material used to manufacture the Precision7™ (serafilcon A) lens. See the following table for a summary of results. PMA P220007: FDA Summary of Safety and Effectiveness Data 10 of 53 {10} Table 4. Physicochemical Tests | Test | Purpose | Acceptance Criteria | Results | | --- | --- | --- | --- | | Preservative Uptake and Release | To determine the preservative uptake and release of the contact lens material | N/A | No significant uptake of polyquaternium-1 (POLYQUAD®), ALDOX® myristamidopropyl dimethylamine (ALDOX®), polyhexamethylene biguanide (PHMB), or Alexidine. | | Compatibility with Lens Care Products | To determine compatibility of contact lens care products with contact lenses | After 7-cycles¹, contact lens parameters should be within the tolerance² of the initial parameters before cycling | Pass | | Extractables – Leachability | To determine if any monomer, initiator, or tint leached out during extraction with water | N/A | No detectable levels of monomers, initiator, or tint were found in any of the phosphate buffered saline (PBS) leachate. | | Extractables - Soxhlet Extraction | The quantity of extractables from the Soxhlet extraction | N/A | The extractables ranged from 0% - 0.5% for water and 1.6% - 2.2% for 2-propanol | ¹ 7-cycles were accepted as Precision 7™ (serafilcon A) contact lenses are indicated for continuous wear up to 6 nights. ² Contact lens tolerances per ISO 18369-2: Ophthalmic optics – Contact lenses – Part 2: Tolerances. PMA P220007: FDA Summary of Safety and Effectiveness Data {11} # 3. Sterilization, Bioburden, and Shelf Life Finished contact lenses in buffered saline are provided sterile and individually packaged in sealed blister packs (blister shell and lidding). The packaged lenses are steam sterilized in a validated autoclave. Blister pack containers are labeled with variable information such as the lens parameters, lot number, and product expiration date. The expiration date has been established through stability studies that have assessed the chemical and physical stability of the lens and package integrity. Routine bioburden testing is performed prior to sterilization every week during lens production. This testing provides an assessment of the cleanliness of the devices being manufactured and the facility in general. The bioburden test method was validated in accordance with ISO Standard 11737-1:2006, "Sterilization of health care products – Microbiological methods – Part 1: Determination of the population of microorganisms on product." The contact lenses are terminally sterilized by subjecting the finished device to moist heat sterilization. The moist heat sterilization cycle was validated using the overkill method (partial cycle approach) in accordance with Annex D of ISO Standard 17665-1:2006, "Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of sterilization process for medical devices." The sterilization process for the device was validated to achieve a Sterility Assurance Level (SAL) of $10^{-6}$. Shelf-life studies have been conducted to verify that the packaging for the subject contact lenses maintains a sterile barrier and adequately protects the device through the expiration date on the package label, which is 7 years from the date of sterilization. Shelf-life testing has also been conducted to verify that device physical and optical properties satisfy the requirements of the engineering drawings and product specification document through the 7-year labeled expiration date. All test samples satisfied all acceptance criteria (see Table 4). PMA P220007: FDA Summary of Safety and Effectiveness Data 12 of 53 {12} Table 5: Sterility, Bioburden, and Shelf Life | Test | Purpose | Acceptance Criteria | Results | | --- | --- | --- | --- | | Bioburden Testing | Evaluate the cleanliness of the devices being manufactured and facility in general | Vegetative growth: Alert: ≤ 600 CFU (colony forming units)/device Action: ≤ 1,000 CFU/device Spores: Alert: ≤ 10 CFU/device Action: ≤ 20 CFU/device | Pass | | Moist Heat Sterilization Validation | Evaluate the efficacy of the sterilization process | No growth is detected in the internal process challenge device/biological indicators | Pass | | Package Evaluation Validated Container Closure Integrity Testing (CCIT: Vacuum Decay) | Evaluate whole package integrity | No evidence of vacuum-based leak | Pass | | Validated Sterility Testing | Evaluate sterility | Negative for growth | Pass | | Shelf-life | To establish the expiration date | Finished Product Specifications | 7 years | PMA P220007: FDA Summary of Safety and Effectiveness Data {13} # X. SUMMARY OF PRIMARY CLINICAL STUDY The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of the Alcon Precision7™ (serafilcon A) soft contact lenses when worn for up to 7 days of extended wear for the optical correction of refractive ammetropia and presbyopia in persons with non-diseased eyes in the US under IDE #G190046. Data from this clinical study were the basis for the PMA approval decision. A summary of the clinical study is presented below. ## A. Study Design Patients were treated between October 11, 2019 and March 26, 2021. The database for this PMA reflected data collected through March 26, 2021 and included 608 enrolled patients (1216 eyes). There were 35 primary cohort investigational sites. Among those patients enrolled, 27 subjects (54 eyes) were screen failures, and 581 subjects (1162 eyes) were dispensed study lenses. The study was a prospective, multi-center, parallel group, randomized, stratified (by corneal curvature radius), double-blinded, 12-month clinical study. Subjects were randomized in 1:1 ratio to one of the two study groups. There were 290 subjects (580 eyes) randomized to the Alcon serafilcon A investigational group and 291 subjects (582 eyes) to the CooperVision® Biofinity® (comfilcon A) control group. Both test and control lenses were replaced weekly, after each week of extended wear, throughout the duration of study participation. For the purposes of this study, extended wear meant that lenses were to be applied and worn around the clock, including during sleep. Weekly extended wear meant at the end of any six (6) consecutive nights of extended wear, the subject had to remove the lens for one night prior to beginning a new cycle of lens wear. The primary safety endpoint was the proportion of ocular serious and significant non-serious adverse device effects (ADEs). The primary safety analysis was based on noninferiority, with a predefined margin of 0.05. The null hypothesis stated that the difference in this proportion between serafilcon A lens group and comfilcon A lens group (serafilcon A minus comfilcon A) was 0.05 (5%) or more. The alternative hypothesis stated that the difference in this proportion was less than 0.05. Therefore, rejection of the null hypothesis supports noninferiority of serafilcon A compared to comfilcon A. A generalized linear model with a logit link function was used, and a one-sided 95% upper confidence limit (UCL) was calculated for the difference in proportions between two lens groups. The primary effectiveness endpoint was high contrast distance visual acuity (VA) with study lenses, obtained at the Screening/Dispensing Visit, and at each of the follow-up visits. Scores were recorded as the number of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR). Counts and percentages on the Snellen categories were displayed, and descriptive statistics (number of observations, mean, standard PMA P220007: FDA Summary of Safety and Effectiveness Data {14} deviation, median, minimum, and maximum) for the converted logMAR values were provided for each lens group, at each scheduled visit and all unscheduled visits combined. For all remaining endpoints collected, continuous data were summarized using descriptive statistics: n, mean, median, standard deviation (SD), minimum, and maximum. Categorical data were presented by the total counts for each category and corresponding percentages. Sample size calculation was based on the primary safety endpoint. Assuming that the expected difference between serafilcon A and comfilcon A was 0 and that the proportion in comfilcon A was 0.045, a sample size of 213 per group provided 80% power to reject the null hypothesis of inferiority in serafilcon A compared to comfilcon A, with a noninferiority margin of 0.05 (5%). Taking into consideration the long exposure/study duration of 12 months, a total of 568 subjects were planned to be randomized (284 test and 284 control) to compensate for approximately 25% drop-out rate. Alcon representatives monitored all study site locations to assess the data, quality, and study integrity in a manner consistent with applicable health authority regulations and the procedures adopted by Alcon. Monitoring visits and telephone consultations occurred as necessary, or per the monitoring plan, to verify that the rights and well-being of subjects were protected, the conduct of the investigation was in compliance with the currently approved protocol, the integrity of the data was maintained, the facilities remained acceptable, and test article accountability was ensured. The control group was an active control; the control treatment, CooperVision® Biofinity® (comfilcon A) Contact Lenses, is a legally marketed alternative with similar indications for use. 1. Clinical Inclusion and Exclusion Criteria Enrollment in the study was limited to patients who met the following key inclusion criteria: at least 18 years of age as of the date of initial evaluation, required lens powers between requiring contact lens sphere power from +0.50 to +4.00 diopters sphere or -0.50 to -6.00 diopters sphere, with at least one eye requiring contact lens sphere power greater than or equal to ±1 diopters sphere with no more than 0.75D diopters of refractive astigmatism and were willing to wear lenses in both eyes, and were correctable to visual acuities of at least 20/25 in each eye with spectacles, and as specified otherwise in the study protocol. Patients were not permitted to enroll in the study if they met any of the following key exclusion criteria: if they had participated in a clinical trial within the previous 30 days or were participating at the time of this study, had previous refractive surgery or current or previous orthokeratology treatment, had clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, had ocular or systemic disease or need for medication PMA P220007: FDA Summary of Safety and Effectiveness Data 15 of 53 {15} which might interfere with contact lens wear, or had slit lamp findings that would contraindicate contact lens wear, or were pregnant or breast feeding, or were monovision contact lens wearers, and as specified in the study protocol. ## 2. Follow-up Schedule All patients were scheduled to return for follow-up examinations at baseline/dispense, 24 hours, 1 week, 1 month, 2 months, 3 months, 6 months, 9 months and 12 months during the study. All subjects were evaluated at Baseline/Dispense and followed up according to the visit schedule below (Table 6). Table 6: Study Visit Schedule | Visit | Description | Target | Visit Window | | --- | --- | --- | --- | | 1 | Baseline/Dispense | Day 1 | N/A | | 2 | 24-Hour follow-up | Day 2 | ± 4 hours | | 3 | 1-Week follow-up | Day 7 | ± 2 days | | 4 | 1-Month follow-up | Day 30 | ± 4 days | | 5 | 2-Month follow-up | Day 60 | ± 7 days | | 6 | 3-Month follow-up | Day 90 | ± 7 days | | 7 | 6-Month follow-up | Day 189 | -7 / + 14 days | | 8 | 9-Month follow-up | Day 270 | ± 14 days | | 9 | 12-Month follow-up | Day 365 | ± 14 days | At the screening/dispensing visit, a slit lamp biomicroscope examination was conducted, a spherocylindrical refraction (and best spectacle corrected visual acuity (BCVA)) was measured, and keratometry was performed. Following the contact lens fitting, symptoms/complaints were assessed, distance high contrast visual acuity was measured, contact lens over-refraction and visual acuity were measured, and lens wettability, deposits, centration and movement were assessed. Follow-up visits were scheduled for 24 hours, 1 week, and 1-, 3-, 6-, 9-, and 12- months after starting extended wear. At follow-up visits, the slit lamp examination was repeated, high contrast visual acuity, symptoms/complaints, average wear time, keratometry changes, adverse events, PMA P220007: FDA Summary of Safety and Effectiveness Data 16 of 53 {16} reasons for discontinuation, lens wettability, deposits and lens fit (movement and centration), lens wear and lens replacement data were assessed. Adverse events and device deficiencies were recorded at all visits. Contact lenses were replaced weekly. At scheduled visits, randomized subjects were given enough lenses to last until the next study visit, allowing for scheduled and unplanned lens replacements. If a subject visit occurred between any regularly scheduled visits, this visit was documented as an Unscheduled Visit. The key timepoints are shown below in the tables summarizing safety and effectiveness. ## 3. Clinical Endpoints With regards to safety, the primary safety endpoint was the proportion of ocular serious and significant non-serious adverse device effects (ADEs) during the study. Serious adverse events are those events that may result in death, or have potential to cause, either permanent impairment of an ocular function or damage to an ocular structure, and may necessitate medical or surgical intervention. Serious adverse events may include any hazardous, sight-threatening conditions occurring after exposure to the study lenses, including the following: - An ocular infection including a presumed infectious ulcer with any of the characteristics including central or paracentral location, penetration of Bowman’s membrane, infiltrates &gt;2 mm diameter, iritis, increase in intraocular pressure, culture positive for microorganisms, increasing size or severity at subsequent visits); - Any central or paracentral corneal event (such as neovascularization) that results in permanent opacification; - Hypopyon, hyphema, or neovascularization within the central 6 mm of the cornea; - Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment visit that fails to resolve; - Uveitis (anterior, intermediate, or posterior); - Corneal abrasion affecting ≥ 50% of corneal surface area. A significant nonserious AE was defined as a device-related, non-sight threatening AE that warrants discontinuation of any contact lens wear for greater than or equal to 2 weeks due to - Peripheral non-progressive non-infectious ulcers; - All symptomatic corneal infiltrative events; - Corneal staining score greater than or equal to Grade 3; PMA P220007: FDA Summary of Safety and Effectiveness Data 17 of 53 {17} o Temporary vision loss as defined by loss of 2 or more lines of BCVA from enrollment visit that persists for 2 or more weeks; o Neovascularization score greater than or equal to Grade 2. The primary safety analysis was to demonstrate that the proportion of serious and significant non-serious adverse device effects in eyes dispensed with the test lens (serafilcon A) was not inferior to the proportion of serious and significant non-serious adverse device effects with the control lens (comfilcon A). Other safety parameters included protocol-defined adverse events not included in the primary safety analysis (e.g., ocular non-serious non-significant AEs, other SAEs and non-serious AEs determined to be not related to study device), discontinuations, and biomicroscopy findings. With regards to effectiveness, the primary effectiveness endpoint was high contrast, distance visual acuity (VA) measured with study lenses. No hypothesis testing on the primary effectiveness endpoint was planned. For the primary and each of the supportive effectiveness endpoints, separate summaries were prepared, when applicable, for the Completed and the Discontinued analysis sets as follows: Completed Control (eyes/subjects), Completed Test (eyes/subjects), Discontinued Control (eyes/subjects), Discontinued Test (eyes/subjects). Safety analyses was conducted using the safety analysis set on a treatment-emergent basis, and effectiveness endpoints were analyzed using the Eligible Dispensed population. With regards to success/failure criteria, the applicant did not define any specific study success criteria beyond the safety and effectiveness endpoints. ## B. Accountability of PMA Cohort At the time of database lock, of the 608 subjects enrolled in the PMA study, all data (100%, 608 subjects) were available for analysis at the completion of the study; the 12-month safety and effectiveness data based on enrolled dispensed serve as the basis for approval of the PMA submission. Of the 608 subjects enrolled, 27 (54 eyes) were ineligible at baseline. Of the 608 enrolled subjects, 581 subjects (1162 eyes) were dispensed lenses in the PMA study, 513 (88.3%) eligible subjects (1,026 eyes) completed the 12-month visit, 68 (11.7%) eligible subjects (136 eyes) were discontinued. Subject accountability is presented in Table 7. Reasons for subject discontinuations is presented in Table 8. PMA P220007: FDA Summary of Safety and Effectiveness Data {18} Table 7: Subject Accountability (All Enrolled Subjects) | | Status | Serafilcon A number of subjects | Comfilcon A number of subjects | Overall number of subjects | | --- | --- | --- | --- | --- | | Screen Failures | | | | 27 | | | | | | | | Enrolled Dispensed | | | | | | | Completed | 257 | 256 | 513 | | | Discontinued | 33 | 35 | 68 | | | Total Dispensed (Visit Attended) | | | | | | Dispense | 290 | 291 | 581 | | | 24-Hour Follow-up | 290 | 288 | 578 | | | 1-Week Follow-up | 287 | 283 | 570 | | | 1-Month Follow-up | 277 | 276 | 553 | | | 2-Month Follow-up | 264 | 270 | 534 | | | 3-Month Follow-up | 270 | 275 | 545 | | | 6-Month Follow-up | 263 | 268 | 531 | | | 9-Month Follow-up | 259 | 259 | 518 | | | 12-Month Follow-up | 257 | 256 | 513 | | Enrolled Not Dispensed | | | | 27 | | Total Enrolled | | | | 608 | PMA P220007: FDA Summary of Safety and Effectiveness Data {19} Table 8: Subject Disposition (All Enrolled Subjects) | | Serafilcon A n (%) | Comfilcon A n (%) | Overall n (%) | | --- | --- | --- | --- | | Total enrolled | | | 608 | | Screen failures | | | 27 | | Discontinued prior to randomization | | | 0 | | Randomized | 290 | 291 | 581 | | | | | | | As Treated | | | | | Enrolled Dispensed | 290 | 291 | 581 | | Completed the study | 257 (88.6) | 256 (88.0) | 513 (88.3) | | Discontinued from study | 33 (11.4) | 35 (12.0) | 68 (11.7) | | Adverse Event | 7 (2.4) | 8 (2.7) | 15 (2.6) | | Lost to Follow Up | 2 (0.7) | 7 (2.4) | 9 (1.5) | | Physician Decision | 1 (0.3) | 0 (0.0) | 1 (0.2) | | Pregnancy | 1 (0.3) | 0 (0.0) | 1 (0.2) | | Withdrawal by Subject | 16 (5.5) | 15 (5.2) | 31 (5.3) | | Other | 6 (2.1) | 5 (1.7) | 11 (1.9) | Percentages calculated as (n/Enrolled Dispensed) * 100 Total enrolled = Total number of subjects consented. ## C. Study Population Demographics and Baseline Parameters The demographics of the study population are typical for a randomized, prospective, multi-center clinical study performed in the United States. Table 9 presents the demographic data for the serafilcon A test group vs. the comfilcon A control group. Subject demographics were similar between the two lens groups. The mean age was 34.1 PMA P220007: FDA Summary of Safety and Effectiveness Data {20} and 33.5 years for the test lens group and control lens group, respectively. Females represented more than half of both lens groups, and majority of subjects in both lens groups were white. Table 9: Demographic Characteristics (Enrolled Dispensed Subjects) | | Serafilcon A (N = 290) | Comfilcon A (N = 291) | Overall (N = 581) | | --- | --- | --- | --- | | Age (Years) | | | | | n | 290 | 291 | 581 | | Mean (SD) | 34.1 (9.6) | 33.5 (8.4) | 33.8 (9.0) | | Median | 33.5 | 33.0 | 33.0 | | (Min, Max) | (18, 69) | (18, 61) | (18, 69) | | | | | | | Sex, n (%) | | | | | Male | 112 (38.6) | 113 (38.8) | 225 (38.7) | | Female | 178 (61.4) | 178 (61.2) | 356 (61.3) | | Ratio (Females/Males) | 1.6 | 1.6 | 1.6 | | | | | | | Race, n (%) | | | | | White | 262 (90.3) | 254 (87.3) | 516 (88.8) | | Black or African American | 15 (5.2) | 22 (7.6) | 37 (6.4) | | American Indian or Alaska Native | 1 (0.3) | 1 (0.3) | 2 (0.3) | | Asian | 3 (1.0) | 3 (1.0) | 6 (1.0) | | Native Hawaiian or Other Pacific Islander | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Other | 9 (3.1) | 8 (2.7) | 17 (2.9) | | Multi-racial | 0 (0.0) | 3 (1.0) | 3 (0.5) | | | | | | PMA P220007: FDA Summary of Safety and Effectiveness Data 21 of 53 {21} | Ethnicity, n (%) | | | | | --- | --- | --- | --- | | Hispanic or Latino | 32 (11.0) | 28 (9.6) | 60 (10.3) | | Not Hispanic or Latino | 257 (88.6) | 263 (90.4) | 520 (89.5) | | Not Reported | 1 (0.3) | 0 (0.0) | 1 (0.2) | Percentages calculated as (n/N) * 100 ## D. Safety and Effectiveness Results ### 1. Safety Results The analysis of safety was based on the enrolled dispensed cohort of 581 patients/procedures, etc. available for the 12 month evaluation. The key safety outcomes for this study are presented below in Table 10. Adverse effects are reported in Tables 11 to 14. The study investigators were required to report all adverse events by diagnosis and by severity. Adverse events were graded as Serious, Significant and Non-Significant based on the definitions provided in the study protocol. The safety analysis was based on the 1162 enrolled dispensed eyes (581 subjects): 580 eyes (290 subjects) in serafilcon A and 582 eyes (291 subjects) in comfilcon A. The key safety outcomes for this study is presented below in Table 10. ### a. Primary safety The primary safety endpoint was proportion of ocular serious and significant non-serious adverse device effects (ADEs). Noninferiority of test to control for primary safety was met using a predetermined threshold of 0.05 (5.0%). There were no serious adverse events (SAE) reported for the test group. There were 3 ocular device-related SAEs in the control group in 3 eyes (3 ulcerative keratitis). All three events resolved, and 1 subject discontinued from the study due to the SAE. Overall, 1.0% (6/580) of the test eyes experienced significant non-serious ADEs during the study, compared to 2.1% (12/582) of the control eyes. In the test group, there were 6 device-related events in 6 eyes (4 corneal infiltrates, 2 ulcerative keratitis). In the control group, there were 12 device-related events in 12 eyes (6 corneal infiltrates, 3 giant papillary conjunctivitis, 3 ulcerative keratitis). The incidence rates of eyes with ocular device-related serious, and significant non-serious adverse events are presented in Table 10. PMA P220007: FDA Summary of Safety and Effectiveness Data {22} Table 10: Incidence of Ocular Serious and Significant Non-serious Adverse Device Effects (Enrolled Dispensed Eyes) | | Serafilcon A (N = 580) | | Comfilcon A (N = 582) | | | --- | --- | --- | --- | --- | | Preferred Term | n | (%) | n | (%) | | Serious | | | | | | Any Adverse Event | 0 | (0.0) | 3 | (0.5) | | Ulcerative keratitis | 0 | (0.0) | 3 | (0.5) | | | | | | | | Significant Non-serious | | | | | | Any Adverse Event | 6 | (1.0) | 12 | (2.1) | | Corneal infiltrates | 4 | (0.7) | 6 | (1.0) | | Giant papillary conjunctivitis | 0 | (0.0) | 3 | (0.5) | | Ulcerative keratitis | 2 | (0.3) | 3 | (0.5) | | | | | | | n = Number of eyes reporting specified adverse event.<br/> Percentages calculated as (n/N) * 100 b. Other adverse events (non-primary safety AEs) The majority of the AEs in the study were assessed as non-serious and non-significant. The overall rate of other ocular AEs were similar between groups. There were a total of 97 ocular adverse events in the test group, of which 35 events (29 eyes) were related to the device (5% of total 580 eyes dispensed). The two most frequently reported device-related AE in the test group were dry eye (8 events) and GPC (6 events). In the control group, there were a total of 102 events, of which 25 events were device-related in 24 eyes (4.1% of total 582 eyes dispensed). Commonly observed related AEs in the control group included corneal infiltrates, corneal edema, and eye irritation (n=3 events each). Table 11 summarizes the outcomes for Other Adverse Events. PMA P220007: FDA Summary of Safety and Effectiveness Data {23} Table 11: Incidence of Other Treatment-Emergent Adverse Events (Enrolled Dispensed Eyes) | | Related | | | | | | Not Related | | | | | | Overall | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | - | | | - | | Serafilcon A (N = 580) | - | | | - | | Serafilcon A (N = 580) | - | | | - | | Serafilcon A (N = 582) | | Preferred Term | n | (%) | E | n | (%) | E | n | (%) | E | n | (%) | E | n | (%) | E | n | (%) | E | | Any Adverse Event | 29 | (5.0) | 35 | 24 | (4.1) | 25 | 59 | (10.2) | 62 | 65 | (11.2) | 77 | 81 | (14.0) | 97 | 84 | (14.4) | 102 | | Allergic keratitis | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 1 | (0.2) | 1 | 1 | (0.2) | 1 | 1 | (0.2) | 1 | | Blepharitis allergic | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | | Chalazion | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 3 | (0.5) | 4 | 1 | (0.2) | 1 | 3 | (0.5) | 4 | 1 | (0.2) | 1 | | Chemical burns of eye | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | | Ciliary hyperaemia | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | | Conjunctival disorder | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | | Conjunctival haemorrhage | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 2 | (0.3) | 2 | 2 | (0.3) | 2 | 2 | (0.3) | 2 | | Conjunctival hyperaemia | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 1 | (0.2) | 1 | 1 | (0.2) | 1 | 1 | (0.2) | 1 | 3 | (0.5) | 3 | | Conjunctival oedema | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 4 | (0.7) | 4 | 0 | (0.0) | 0 | 4 | (0.7) | 4 | | Conjunctivitis | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 3 | (0.5) | 3 | 4 | (0.7) | 4 | 3 | (0.5) | 3 | 4 | (0.7) | 4 | | Conjunctivitis allergic | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 5 | (0.9) | 6 | 4 | (0.7) | 4 | 5 | (0.9) | 6 | 4 | (0.7) | 4 | | Conjunctivitis viral | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | | Contact lens acute red eye | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | | Corneal abrasion | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 2 | (0.3) | 2 | 3 | (0.5) | 3 | 2 | (0.3) | 2 | PMA P220007: FDA Summary of Safety and Effectiveness Data 24 of 53 {24} PMA P220007: FDA Summary of Safety and Effectiveness Data 25 of 53 | Corneal epithelial microcysts | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Corneal epithelium defect | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | | Corneal infiltrates | 1 | (0.2) | 1 | 3 | (0.5) | 3 | 4 | (0.7) | 4 | 2 | (0.3) | 2 | 5 | (0.9) | 5 | 5 | (0.9) | 5 | | Corneal oedema | 0 | (0.0) | 0 | 3 | (0.5) | 3 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 5 | (0.9) | 5 | | Corneal scar | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 2 | (0.3) | 2 | | Curetting of chalazion | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | | Dry eye | 8 | (1.4) | 8 | 2 | (0.3) | 2 | 7 | (1.2) | 7 | 5 | (0.9) | 5 | 13 | (2.2) | 15 | 7 | (1.2) | 7 | | Episcleritis | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | | Eye allergy | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 3 | (0.5) | 3 | 0 | (0.0) | 0 | 5 | (0.9) | 5 | 0 | (0.0) | 0 | | Eye discharge | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | | Eye irritation | 3 | (0.5) | 3 | 3 | (0.5) | 3 | 5 | (0.9) | 5 | 7 | (1.2) | 8 | 8 | (1.4) | 8 | 10 | (1.7) | 11 | | Eye pain | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | | Eye pruritus | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | | Eyelid disorder | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | | Eyelid erosion | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | | Eyelid injury | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | | Eyelid pain | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | | Facial paralysis | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | | Foreign body in eye | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 3 | (0.5) | 3 | 1 | (0.2) | 1 | 3 | (0.5) | 3 | | Foreign body sensation in eyes | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 1 | (0.2) | 1 | 4 | (0.7) | 4 | 1 | (0.2) | 1 | 5 | (0.9) | 5 | | Giant papillary conjunctivitis | 6 | (1.0) | 6 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 6 | (1.0) | 6 | 4 | (0.7) | 4 | | Hordeolum | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 4 | (0.7) | 4 | 2 | (0.3) | 2 | 4 | (0.7) | 4 | 2 | (0.3) | 2 | | Hypopyon | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | | Keratitis | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 1 | (0.2) | 1 | 2 | (0.3) | 2 | | Keratitis bacterial | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | {25} | Muscle twitching | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Ocular discomfort | 2 | (0.3) | 2 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 4 | (0.7) | 4 | 2 | (0.3) | 2 | 6 | (1.0) | 6 | | Ocular hyperaemia | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 3 | (0.5) | 3 | 0 | (0.0) | 0 | 3 | (0.5) | 3 | 0 | (0.0) | 0 | | Punctate keratitis | 3 | (0.5) | 3 | 1 | (0.2) | 1 | 1 | (0.2) | 1 | 3 | (0.5) | 3 | 4 | (0.7) | 4 | 4 | (0.7) | 4 | | Superficial injury of eye | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | | Swelling of eyelid | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | | Ulcerative keratitis | 1 | (0.2) | 1 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 1 | (0.2) | 1 | 2 | (0.3) | 2 | | Vision blurred | 3 | (0.5) | 3 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 3 | (0.5) | 3 | 1 | (0.2) | 1 | | Visual acuity reduced | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | | Visual impairment | 2 | (0.3) | 2 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 2 | (0.3) | 2 | 0 | (0.0) | 0 | | Vital dye staining cornea present | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | | Vitreoretinal traction syndrome | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | | Vitreous floaters | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | 1 | (0.2) | 1 | 0 | (0.0) | 0 | n = Number of eyes reporting specified adverse event; E = Number of events Percentages calculated as (n/N) * 100 If an eye had multiple occurrences of an adverse event, the eye is presented only once in the respective eye count column (n), and each occurrence is counted each time in the event (E) column. Biomicroscopy findings for each enrolled dispensed eye, assessed at the Screening/ Dispensing Visit (baseline) and all follow-up visits, were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Over All Follow-up Visits, $\geq$ Grade 2 findings were noted in 152 $(26.2\%)$ eyes in the test group and 154 $(26.6\%)$ eyes in the control group. Table 12 provides summary for each group for eyes with slit lamp findings $\geq$ Grade 2. PMA P220007: FDA Summary of Safety and Effectiveness Data {26} Table 12: Graded Slit Lamp Findings Over All Follow-up Visits, Eyes with Findings ≥ Grade 2 (Enrolled Dispensed Eyes) | Finding | | Serafilcon A (N = 580) n (%) | Comfilcon A (N = 582) n (%) | | --- | --- | --- | --- | | Any Finding | Absent | 428 ( 73.8) | 424 ( 73.4) | | | Present | 152 ( 26.2) | 154 ( 26.6) | | Limbal Hyperemia | Absent | 550 ( 94.8) | 554 ( 95.8) | | | Present | 30 ( 5.2) | 24 ( 4.2) | | Bulbar Hyperemia | Absent | 537 ( 92.6) | 544 ( 94.1) | | | Present | 43 ( 7.4) | 34 ( 5.9) | | Corneal Staining | Absent | 547 ( 94.3) | 526 ( 91.0) | | | Present | 33 ( 5.7) | 52 ( 9.0) | | Conjunctival Staining | Absent | 525 ( 90.5) | 520 ( 90.0) | | | Present | 55 ( 9.5) | 58 ( 10.0) | | Palpebral Conjunctival Observations | Absent | 504 ( 86.9) | 508 ( 87.9) | | | Present | 76 ( 13.1) | 70 ( 12.1) | | Corneal Epithelial Edema | Absent | 577 ( 99.5) | 574 ( 99.3) | | | Present | 3 ( 0.5) | 4 ( 0.7) | | Corneal Stromal Edema | Absent | 579 ( 99.8) | 575 ( 99.5) | | | Present | 1 ( 0.2) | 3 ( 0.5) | | Corneal Vascularization | Absent | 579 ( 99.8) | 576 ( 99.7) | | | Present | 1 ( 0.2) | 2 ( 0.3) | | Corneal Infiltrates | Absent | 580 (100.0) | 574 ( 99.3) | | | Present | 0 ( 0.0) | 4 ( 0.7) | PMA P220007: FDA Summary of Safety and Effectiveness Data 27 of 53 {27} PMA P220007: FDA Summary of Safety and Effectiveness Data Other Findings | Absent | 564 ( 97.2 ) | 566 ( 97.9 ) ---|---|---|--- | Present | 16 ( 2.8 ) | 12 ( 2.1 ) Percentages calculated for each category use total non-missing as denominator Present = finding ≥ grade 2 for category at least once across all follow-up visits. Table 13 presents Eyes with device-related Medically Treated serious and significant non serious Adverse Events. There were 6 (1.0%, 6/580) Serafilcon A test lens related events compared to 14 (2.4%, 14/582) Comfilcon A control lens related events that were medically treated. Table 13: Eyes with Medically Treated Serious and Significant Non-serious Adverse Device Effects (Enrolled Dispensed Eyes) | | | Serafilcon A (N = 580) n (%) | Comfilcon A (N = 582) n (%) | | --- | --- | --- | --- | | Eyes with medically treated serious or significant non-serious ADEs | Yes | 6 ( 1.0 ) | 14 ( 2.4 ) | | | No | 574 ( 99.0 ) | 568 ( 97.6 ) | | | Total | 580 | 582 | N = Number of eyes in each lens; n = Number of eyes in specified category Total = Number of eyes with non-missing response; Percentages calculated as (n/Total) * 100 Ungraded slit lamp findings were marked as either present or absent for each eye. Over All Follow-up Visits, for conjunctival compression or chemosis, there were 104 (17.9%) eyes in the serafilcon A test group, and 124 (21.5%) eyes in the comfilcon A control group with these slit lamp findings. Table 14 presents the ungraded slit lamp findings for the Test and Control groups, based upon all enrolled dispensed eyes across all follow-up visits. 28 of 53 {28} Table 14: Ungraded Slit Lamp Findings (Enrolled Dispensed Eyes) | | | Serafilcon A (N = 580) n (%) | Comfilcon A (N = 582) n (%) | | --- | --- | --- | --- | | Baseline | Absent | 570 (98.3) | 575 (98.8) | | | Present | 10 (1.7) | 7 (1.2) | | Over All Follow-up Visits | Absent | 476 (82.1) | 454 (78.5) | | | Present | 104 (17.9) | 124 (21.5) | | 24-Hour Follow-up | Absent | 545 (94.0) | 549 (95.3) | | | Present | 35 (6.0) | 27 (4.7) | | 1-Week Follow-up | Absent | 525 (93.1) | 542 (95.8) | | | Present | 39 (6.9) | 24 (4.2) | | 1-Month Follow-up | Absent | 490 (93.5) | 499 (94.5) | | | Present | 34 (6.5) | 29 (5.5) | | 2-Month Follow-up | Absent | 469 (94.2) | 479 (94.3) | | | Present | 29 (5.8) | 29 (5.7) | | 3-Month Follow-up | Absent | 489 (97.0) | 500 (95.4) | | | Present | 15 (3.0) | 24 (4.6) | | 6-Month Follow-up | Absent | 496 (95.8) | 494 (93.2) | | | Present | 22 (4.2) | 36 (6.8) | | 9-Month Follow-up | Absent | 494 (95.4) | 481 (93.6) | | | Present | 24 (4.6) | 33 (6.4) | | 12-Month Follow-up | Absent | 484 (94.2) | 479 (93.6) | | | Present | 30 (5.8) | 33 (6.4) | | Unscheduled Visits | Absent | 186 (93.9) | 174 (92.6) | PMA P220007: FDA Summary of Safety and Effectiveness Data 29 of 53 {29} High contrast distance best spectacle corrected visual acuity (BCVA) was obtained at the Screening/Dispensing Visit (baseline) and again at the Exit Visit. VA was collected in the Snellen scale and converted to the logMAR scale based on the number of letters correctly identified. An eye was considered to have worsened 2 or more Snellen lines if the difference in logMAR VA ≥ 0.2 (exit BCVA – baseline BCVA). Over All Follow-up Visits, there were no eyes in either group with a 2 or more line decrease in BSCVA from baseline to exit (refer to Table 15). Table 15: Change from Baseline in Best Spectacle Corrected Visual Acuity: Baseline BCVA vs Final BCVA (Enrolled Dispensed Eyes) | | | Serafilcon A (N = 580) n (%) | Comfilcon A (N = 582) n (%) | | --- | --- | --- | --- | | Change from Baseline | Absent | 554 (100.0) | 548 (100.0) | | | Present | 0 (0.0) | 0 (0.0) | Percentages calculated for each category use total non-missing as denominator Present = 2 or more line decrease in BCVA. Symptoms, problems and complaints were noted at each study visit for each eye. Subject responses were binary (absent or present). Each of the symptoms were reported by the subject on their own accord, and responses were reviewed by the investigator during the visit. The proportion of the eyes that reported 'absent' or 'present' for each of the symptoms over the duration of the study was similar between the test and the control groups and is presented in Table 16. PMA P220007: FDA Summary of Safety and Effectiveness Data {30} Table 16: Summary of Symptoms, Problems, and Complaints (SPC) Over All Follow-up Visits (Enrolled Dispensed Eyes) | | | Serafilcon A (N = 580) n (%) | Comfilcon A (N = 582) n (%) | | --- | --- | --- | --- | | Burning/Stinging | Absent | 543 (93.6) | 537 (92.9) | | | Present | 37 (6.4) | 41 (7.1) | | Itching | Absent | 507 (87.4) | 522 (90.3) | | | Present | 73 (12.6) | 56 (9.7) | | Lens Awareness | Absent | 474 (81.7) | 471 (81.5) | | | Present | 106 (18.3) | 107 (18.5) | | Dryness | Absent | 246 (42.4) | 279 (48.3) | | | Present | 334 (57.6) | 299 (51.7) | | Discomfort | Absent | 473 (81.6) | 444 (76.8) | | | Present | 107 (18.4) | 134 (23.2) | | Blurred Vision | Absent | 484 (83.4) | 512 (88.6) | | | Present | 96 (16.6) | 66 (11.4) | | Fluctuating/Variable Vision | Absent | 538 (92.8) | 549 (95.0) | | | Present | 42 (7.2) | 29 (5.0) | | Halo | Absent | 574 (99.0) | 558 (96.5) | | | Present | 6 (1.0) | 20 (3.5) | | Lens needs cleaning | Absent | 523 (90.2) | 527 (91.2) | | | Present | 57 (9.8) | 51 (8.8) | | Redness | Absent | 525 (90.5) | 526 (91.0) | | | Present | 55 (9.5) | 52 (9.0) | PMA P220007: FDA Summary of Safety and Effectiveness Data {31} | Excessive Tearing | Absent | 560 (96.6) | 557 (96.4) | | --- | --- | --- | --- | | | Present | 20 (3.4) | 21 (3.6) | | Secretions | Absent | 536 (92.4) | 530 (91.7) | | | Present | 44 (7.6) | 48 (8.3) | | Photophobia | Absent | 563 (97.1) | 560 (96.9) | | | Present | 17 (2.9) | 18 (3.1) | | Other | Absent | 540 (93.1) | 549 (95.0) | | | Present | 40 (6.9) | 29 (5.0) | Percentages calculated for each category use total non-missing as denominator Present = SPC reported at least once across all follow-up visits. Table 17 summarizes keratometry changes from baseline to Exit Visit for enrolled dispensed eyes. There were 12 eyes (2.2%) in the test group and 15 eyes (2.7%) in the control group with a change in keratometry (absolute value of &gt;1.00 D), of which 16 were a decrease in at least 1 meridian (9 test and 7 control); none was considered clinically significant. For the majority of all eyes with change in keratometry values, the reasons were indicated by the investigator as erroneous measurements, no apparent reason, visits conducted shortly after lens removal, or movement during measurements. No apparent association to the study lens was noted for all except 1 eye in the test group, however, study lens VA for this eye was 20/15 at all visits, and lens fit was optimal at all follow-up visits. No AEs related to keratometry change were reported. Table 17: Keratometry Change (Absolute Value) from Baseline to Final Visit (Enrolled Dispensed Eyes) | | | Serafilcon A (N = 580) n (%) | Comfilcon A (N = 582) n (%) | | --- | --- | --- | --- | | Maximum Absolute | 0.00 to 1.00 D | 540 (97.8) | 541 (97.3) | | | 1.01 to 1.50 D | 5 (0.9) | 5 (0.9) | | | 1.51 to 2.00 D | 3 (0.5) | 3 (0.5) | PMA P220007: FDA Summary of Safety and Effectiveness Data {32} | | >2.00 D | 4 ( 0.7) | 7 ( 1.3) | | --- | --- | --- | --- | | | Not Reported | 28 | 22 | | | Total | 552 (100.0) | 556 (100.0) | | | | | | | | Mean (SD) | 0.30 (0.39) | 0.36 (0.42) | | | Median | 0.25 | 0.25 | | | (Min, Max) | (0.00, 5.13) | (0.00, 4.18) | | | | | | Percentages calculated as (n/Total) * 100 Based on the absolute change from baseline to final visit Maximum Absolute = maximum of the absolute change of the horizontal and vertical components Baseline = Visit 1; Final = Last attended visit Table 18 summarizes spherocylindrical refraction changes from baseline to Exit Visit for all enrolled dispensed eyes. There were 0 eyes (0.0%) in the test group and 1 eye (0.2%) in the control group with a change in refraction of &gt; 1.00 D. Table 18: Refractive Changes (Absolute Value) from Baseline to Final Visit (Enrolled Dispensed Eyes) | Refractive Changes | | Serafilcon A (N = 580) n (%) | Comfilcon A (N = 582) n (%) | | --- | --- | --- | --- | | | 0.00 to 1.00 D | 556 (100.0) | 549 ( 99.8) | | | 1.12 to 1.50 D | 0 ( 0.0) | 1 ( 0.2) | | | 1.62 to 2.00 D | 0 ( 0.0) | 0 ( 0.0) | | | Not Reported | 24 | 28 | | | Total | 556 (100.0) | 550 (100.0) | | | | | | | | Mean (SD) | 0.10 (0.15) | 0.11 (0.17) | | | Median | 0.00 | 0.00 | | | (Min, Max) | (0.00, 0.00) | (0.00, 0.00) | PMA P220007: FDA Summary of Safety and Effectiveness Data {33} Percentages calculated as (n/Total) * 100 Based on the absolute change from baseline to final visit in spherical equivalent Spherical equivalent = sphere + 1/2 cylinder Baseline = Visit 1; Final = Last attended visit At the start of each follow-up visit, as part of the worn lens evaluation, the subject was asked whether they used rewetting drops. The frequency (count and percent) of subjects using rewetting drops is provided with percent based on the total non-missing responses over all follow-visits, for each lens group (Table 19). Table 19: Rewetting Drop Usage Over All Follow-up Visits (Enrolled Dispensed Subjects) | | | Serafilcon A (N = 290) n (%) | Comfilcon A (N = 291) n (%) | | --- | --- | --- | --- | | Rewetting Drop Usage | Absent | 50 (17.2) | 75 (26.0) | | | Present | 240 (82.8) | 214 (74.0) | Percentages calculated for each category use total non-missing as denominator Present = subject reported rewetting drop use at least once across all follow-up visits 2. Effectiveness Results The analysis of effectiveness was based on the 581 enrolled, dispensed evaluable patients at the 12-month time point. Key effectiveness outcomes are presented in Tables 20 and 21. Visual Acuity The primary effectiveness endpoint was high contrast, distance visual acuity (VA) with dispensed lenses over the 12-month exposure duration. All enrolled dispensed eyes were included in the analysis under the actual treatment received. High contrast distance lens VA was obtained at the Screening/ Dispensing Visit, and at each follow-up visit. Scores were recorded as the numbers of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters). Visual acuity (VA) with the study lenses was measured at each Extended Wear Follow-up visits. For completed eyes, the test group proportion of eyes (all follow-up visits combined) achieving Snellen VA of 20/20 or better was 98.1% (3952/4027) versus the proportion of control eyes PMA P220007: FDA Summary of Safety and Effectiveness Data {34} reporting 20/20 or better (99.0% or 3982/4024). Conversely, the proportion of VAs of 20/40 or worse reported over the duration of the extended wear segment of the study were 0.0% for the test and control groups (Table 20). Overall, the distribution of study lens VA was similar between the test and control eyes. Approximately 99.9% (4247/4253) of enrolled dispensed eyes (completed + discontinued eyes) in the clinical study achieved at least 20/25 with the serafilcon A test contact lens over all follow-up visits. Table 20: Distribution for Snellen Study Lens Visual Acuity Over All Follow-up Visits By Cohort and Status | | Completed Eyes | | Discontinued Eyes | | | --- | --- | --- | --- | --- | | | Serafilcon A (N = 514) n (%) | Comfilcon A (N = 512) n (%) | Serafilcon A (N = 66) n (%) | Comfilcon A (N = 70) n (%) | | ≥20/20 | 3952 (98.1) | 3982 (99.0) | 211 (93.4) | 261 (99.6) | | ≥20/25 | 70 (1.7) | 38 (0.9) | 14 (6.2) | 1 (0.4) | | ≥20/30 | 5 (0.1) | 4 (0.1) | 0 (0.0) | 0 (0.0) | | ≤20/40 | 0 (0.0) | 0 (0.0) | 1 (0.4) | 0 (0.0) | | Total | 4027 | 4024 | 226 | 262 | Percentages calculated for each category use total non-missing as denominator. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters) correctly identified. As shown in Table 21, mean logMAR VA was comparable between the two lens groups in the enrolled dispensed eyes over all follow-up visits. PMA P220007: FDA Summary of Safety and Effectiveness Data 35 of 53 {35} Table 21: Descriptive Statistics for logMAR Study Lens Visual Acuity Over All Follow-up Visits (Enrolled Dispensed Eyes) | | | Serafilcon A (N = 580) | Comfilcon A (N = 582) | | --- | --- | --- | --- | | Visual Acuity | Total | 4253 | 4286 | | | Mean (SD) | -0.05 (0.07) | -0.06 (0.06) | | | Median | 0.00 | 0.00 | | | (Min, Max) | (-0.20, 0.30) | (-0.30, 0.18) | SD = Standard Deviation; Min = Minimum; Max = Maximum Analyses are based on the number of dispensed eyes with non-missing scores in each treatment group With regard to the line change in visual acuity from baseline over all follow-up visits, 9 (1.6%, 9/578) eyes in the test group and 5 (0.9%, 5/576) eyes in the control group experienced a worsening of 2 lines or more from Dispensing Lens VA at any time point. Table 22 presents the line change in visual acuity from baseline over all follow-up visits. Table 22: Study Lens Distance VA Line Change: Screening/Dispensed Lens VA versus Follow-up Lens VA Over All Follow-up Visits (Enrolled Dispensed Eyes) | | | Serafilcon A (N = 580) n (%) | Comfilcon A (N = 582) n (%) | | --- | --- | --- | --- | | Line Change from Dispense | -3 | 3 (0.5) | 1 (0.2) | | | -2 | 6 (1.0) | 4 (0.7) | | | -1 | 139 (24.0) | 106 (18.4) | | | No Change | 421 (72.8) | 460 (79.9) | | | 1 | 9 (1.6) | 5 (0.9) | | | Total | 578 | 576 | Percentages calculated for each category use total non-missing as denominator Over All Follow-up Visits summarizes the worst case over all follow-up visits Negative line change indicates worsened visual acuity; positive indicates improved visual acuity PMA P220007: FDA Summary of Safety and Effectiveness Data {36} # Supportive Effectiveness Endpoints Extended lens wear was reported by subjects using the eDiary. For each week of participation in the study, subjects indicated the number of consecutive nights the lenses were worn during the week. The percentage of diary entries where subjects reported at least six consecutive nights of lens wear per week during the study is shown in Table 23. In the test group, majority of diary entries (91.7%, 19582/21360) indicated that the subjects were able to wear lenses for 6 consecutive nights. Similarly, in the control group, majority of diary entries (92.0%, 20549/22326) indicated that the subjects were able to wear lenses for 6 consecutive nights during the study. Table 23: Number of Nights Lenses Worn (Enrolled Dispensed Eyes) | Diary entries post dispense visit | Serafilcon A N = 580 | | Comfilcon A N = 582 | | | --- | --- | --- | --- | --- | | | n | % | n | % | | Total number of observations | 21360 | 100 | 22326 | 100 | | 6 nights of lens wear | 19582 | 91.7 | 20549 | 92 | Percentages calculated as (n/Total) * 100 Front surface lens wettability was assessed at the Screening/Dispensing Visit on the newly dispensed lens and at each follow-up visit, using a 5-point scale (0 = a smooth uniformly reflecting surface, 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, 2 = one stable dry (non-wetting) area of some magnitude, 3 = more than one stable dry (non-wetting) area of some magnitude, 4 = non-wettable lens surface). Over All Follow-up Visits, the majority of eyes (Test 96.5% (558/578 eyes); and Control 96.9% (558/576 eyes) were assessed with Grade 0 or 1 front surface wettability, and frequency of lenses with Grade 2 were similar between groups (Table 24). There were 2 lenses with grade 3 in the test group. Table 24 presents lens wettability over all follow-up visits. PMA P220007: FDA Summary of Safety and Effectiveness Data {37} Table 24: Lens Wettability Over All Follow-up Visits (Enrolled Dispensed Eyes) | | | Serafilcon A (N = 580) n (%) | Comfilcon A (N = 582) n (%) | | --- | --- | --- | --- | | Front Surface Wettability | 0 | 342 (59.2) | 372 (64.6) | | | 1 | 216 (37.4) | 186 (32.3) | | | 2 | 18 (3.1) | 18 (3.1) | | | 3 | 2 (0.3) | 0 (0.0) | | | 4 | 0 (0.0) | 0 (0.0) | | | Total | 578 | 576 | Percentages calculated for each category use total non-missing as denominator Over All Follow-up Visits summarizes the worst case over all follow-up visits Front surface deposits were assessed at the Screening/Dispensing Visit on the newly dispensed lens and at each follow-up visit, using a 5-point scale (0 = absent, clean surface, 1 = very slight, only visible after tear film drying, 2 = slight, visible deposits easily removable, 3 = moderate, deposits adherent and not removable, 4 = severe, non-removable deposits and comfort affected). Over All Follow-up Visits, the majority of the test and control lenses were assessed with Grade 0 or 1 front surface deposits (Table 25). Grade 2 or higher front surface deposits were observed at a similar rate between the test and control lenses; a few were assessed higher than Grade 2. One (1) lens in each of the test and control group was assessed with Grade 4 deposits. PMA P220007: FDA Summary of Safety and Effectiveness Data {38} Table 25: Front Surface Lens Deposits Over All Follow-up Visits (Enrolled Dispensed Eyes) | | | Serafilcon A (N = 580) n (%) | Comfilcon A (N = 582) n (%) | | --- | --- | --- | --- | | Front Surface Deposits | 0 (Absent) | 318 (55.0) | 304 (52.8) | | | 1 (Very Slight) | 203 (35.1) | 211 (36.6) | | | 2 (Slight) | 51 (8.8) | 52 (9.0) | | | 3 (Moderate) | 5 (0.9) | 8 (1.4) | | | 4 (Severe) | 1 (0.2) | 1 (0.2) | | | Total | 578 | 576 | | Moderate/Severe Lens Deposits | Absent | 572 (99.0) | 567 (98.4) | | | Present | 6 (1.0) | 9 (1.6) | Percentages calculated for each category use total non-missing as denominator Over All Follow-up Visits summarizes the worst case over all follow-up visits Present = lens deposits graded 3 or 4 at least once across all follow-up visits Back surface deposits were assessed at the Screening/Dispensing Visit on the newly dispensed lens and at each follow-up visit, using a 5-point scale (0 = absent, clean surface, 1 = very slight, 3 spots or less of moving particles, 2 = slight, up to 10 spots of moving particles, 3 = moderate, 3 or less non-moving deposits adherent to lens, 4 = severe, 4 or more deposits adherent to the lens and/or corneal indentation). Over All Follow-up Visits, the majority of the test and control lenses in the enrolled dispensed eyes were assessed with Grade 0 or 1 back surface deposits (Table 26). The rates of lenses with Grade 2 or 3 assessments were low across the study visits in both groups (2.1% test (12/578), 3.1% control (18/576)). PMA P220007: FDA Summary of Safety and Effectiveness Data {39} Table 26: Back Surface Lens Deposits Over All Follow-up Visits (Enrolled Dispensed Eyes) | | | Serafilcon A (N = 580) n (%) | Comfilcon A (N = 582) n (%) | | --- | --- | --- | --- | | Back Surface Deposits | 0 (Absent) | 485 ( 83.9) | 450 ( 78.1) | | | 1 (Very Slight) | 81 ( 14.0) | 108 ( 18.8) | | | 2 (Slight) | 9 ( 1.6) | 16 ( 2.8) | | | 3 (Moderate) | 3 ( 0.5) | 2 ( 0.3) | | | 4 (Severe) | 0 ( 0.0) | 0 ( 0.0) | | | Total | 578 | 576 | | Moderate/Severe Lens Deposits | Absent | 575 ( 99.5) | 574 ( 99.7) | | | Present | 3 ( 0.5) | 2 ( 0.3) | Percentages calculated for each category use total non-missing as denominator Over All Follow-up Visits summarizes the worst case over all follow-up visits Present = lens deposits graded 3 or 4 at least once across all follow-up visits Contact lens centration was assessed at the Screening/Dispensing Visit on the newly dispensed lens and at each follow-up visit. Across all follow-up visits, all but one test and all control lenses in the study were reported with optimal or acceptable centration. The majority were assessed optimal (82.5% in the test and 87.8% in the control groups, Table 27). PMA P220007: FDA Summary of Safety and Effectiveness Data {40} Table 27: Lens Centration Over All Follow-up Visits (Enrolled Dispensed Eyes) | | | Serafilcon A (N = 580) n (%) | Comfilcon A (N = 582) n (%) | | --- | --- | --- | --- | | Lens Position | Optimal lens centration | 477 (82.5) | 506 (87.8) | | | Acceptable decentration | 100 (17.3) | 70 (12.2) | | | Unacceptable decentration | 1 (0.2) | 0 (0.0) | | | Total | 578 | 576 | Percentages calculated for each category use total non-missing as denominator Over All Follow-up Visits summarizes the worst case over all follow-up visits Contact lens movement was assessed at the Screening/Dispensing Visit on the newly dispensed lens and at each follow-up visit. Table 28 summarizes lens movement by lens group for enrolled dispensed eyes. In this Table, lens movement is categorized into 3 bins: optimal, acceptably loose or acceptably tight, and unacceptably tight or unacceptably loose. Over All follow-up visits, optimal or acceptable lens movement was reported for all except 1 test lens and 4 control lenses. PMA P220007: FDA Summary of Safety and Effectiveness Data {41} Table 28: Lens Movement Over All Follow-up Visits (Enrolled Dispensed Eyes) | | | Serafilcon A (N = 580) n (%) | Comfilcon A (N = 582) n (%) | | --- | --- | --- | --- | | Lens Movement | Optimal fit/movement | 378 (65.4) | 371 (64.4) | | | Acceptably tight/loose | 199 (34.4) | 201 (34.9) | | | Unacceptably tight/loose | 1 (0.2) | 4 (0.7) | | | Total | 578 | 576 | | Unacceptable Lens Movement | Absent | 577 (99.8) | 572 (99.3) | | | Present | 1 (0.2) | 4 (0.7) | Percentages calculated for each category use total non-missing as denominator Over All Follow-up Visits summarizes the worst case over all follow-up visits Present = unacceptably tight or unacceptably loose at least once across all follow-up visits Contact lens subjective performance was assessed at each scheduled visit for a number of attributes (insertion comfort, insertion handling, overall vision, overall comfort, and removal handling), using a 1 (least favorable outcome) to 10 (most favorable outcome) point scale questionnaire. In the completed eyes, the mean subjective acceptance ratings were similar between the test and control lenses, with ratings $\geq 8.5$ for each of the attributes assessed at the majority of scheduled study visits. In Discontinued eyes, there were no clinically relevant differences in mean subject acceptance ratings between test and control lenses. ## Supplemental Clinical Information The pivotal study protocol (under IDE G190046) also included a separate cohort of Asian patients, to assess in this cohort, the safety and performance of the serafilcon A test lens when worn in an extended wear modality (i.e., up to 6 nights of continuous wear) as compared to comfilcon A control lenses. A total of 67 patients were enrolled at 7 investigative sites in the US. PMA P220007: FDA Summary of Safety and Effectiveness Data {42} Of the 67 enrolled patients, 64 eligible patients were randomized and exposed to study lenses, of which 58 patients completed the study, and were evaluable. Twenty-nine (58 eyes) patients in each group completed the 12-month study. Lenses were replaced on a weekly basis. Data tables summarizing demographics and key safety data pertinent to Asian subjects from the 7 sites are presented in Table 29 and Table 30. Overall mean age of subjects was 33.3 years, with $32.8\%$ (21/64) male and $67.2\%$ (43/64) female participants. Subjects self-identified predominantly as Asian Chinese and Not Hispanic or Latino ethnicity $(100\%, 64/64)$ . Table 29: Demographic Characteristics (Supplemental - Enrolled Dispensed Subjects) | | Control (N = 32) | Test (N = 32) | Overall (N = 64) | | --- | --- | --- | --- | | Age (Years) | | | | | n | 32 | 32 | 64 | | Mean (SD) | 31.6 (7.4) | 34.9 (8.5) | 33.3 (8.1) | | Median | 31.5 | 34.0 | 33.0 | | (Min, Max) | (19, 52) | (18, 51) | (18, 52) | | Sex, n (%) | | | | | Male | 8 (25.0) | 13 (40.6) | 21 (32.8) | | Female | 24 (75.0) | 19 (59.4) | 43 (67.2) | | Ratio (Females/Males) | 3.0 | 1.5 | 2.0 | | Race, n (%) | | | | | White | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Black or African American | 0 (0.0) | 0 (0.0) | 0 (0.0) | | American Indian or Alaska Native | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Asian (Chinese) | 32 (100.0) | 32 (100.0) | 64 (100.0) | | Native Hawaiian or Other Pacific Islander | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Other | 0 (0.0) | 0 (0.0) | 0 (0.0) | PMA P220007: FDA Summary of Safety and Effectiveness Data {43} Ethnicity, n (%) | Hispanic or Latino | 0 ( 0.0) | 0 ( 0.0) | 0 ( 0.0) | | --- | --- | --- | --- | | Not Hispanic or Latino | 32 (100.0) | 32 (100.0) | 64 (100.0) | Control = Biofinity® (comfilcon A) soft contact lenses; Test = Mercury soft contact lenses N = Number of subjects in each lens or overall; n = Number of subjects with non-missing response or in specified category Percentages calculated as (n/N) * 100 SD = Standard Deviation; Min = Minimum; Max = Maximum Primary effectiveness results indicated that for distance visual acuity, all eyes, whether with serafilcon A test or comfilcon A control lens, achieved VA of 20/25 or better throughout the duration of the study, and both lens groups performed similarly with respect to study lens VA. For the primary safety endpoint, there were no reports of ocular serious, and significant non-serious adverse device effects in this cohort, for either lens group. There was 1 device-related non-serious non-significant AE (punctate keratitis) in the test group and no events in the control group (Table 30). There were no ocular Treatment-Emergent adverse events in the di…
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