Clinical Evaluation of Reusable Soft Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study is to confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers.

Detailed Description
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This will be a prospective, multiple day, double (investigator and subject)-masked, randomized, bilateral re-fit parallel arm study comparing Test lenses against appropriate Control lenses. Participants will be randomized to wear either the Test or Control lenses, and the estimated duration of involvement is 4 months.

Official Title
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Clinical Evaluation of Comfilcon A Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Control Lenses (comfilcon A with current process)
* Device: Test Lenses (comfilcon A with novel process)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have had a self-reported oculo-visual examination in the last year. Are at least 18 years of age and has full legal capacity to give their informed consent. Have read and understood the informed consent letter. Are willing and able to follow instructions and maintain the appointment schedule. Have a contact lens spherical prescription between -0.50 D to -6.00 D (inclusive) Are correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. Have spectacle cylinder of ≤ 0.75 D in both eyes. Is a habitual comfilcon A wearer and worn a comfilcon A lens for at least one month (minimum of 8 hours a day, 5 days per week) Currently employ the use of a peroxide or multipurpose solution cleaning and disinfecting regimen in one of the following brand names: Bausch and Lomb BioTrue Multi-Purpose Solution Bausch and Lomb BioTrue Hydration Plus Multi-Purpose Solution Bausch and Lomb ReNu Advanced Formulation Multi-Purpose Solution Alcon Opti-Free Puremoist with Hydraglyde Multi-Purpose Solution Alcon Opti-Free Replenish Multi-Purpose Solution Alcon Clear Care Plus Hydrogen Peroxide Solution Acuvue RevitaLens Multi-Purpose Solution Have clear corneas and no active ocular disease. Have not worn habitual lenses for at least 12 hours before the baseline/screening examination Are willing to wear the study contact lenses for at least 8 hours per day, 5 days per week Exclusion Criteria: Have never worn contact lenses before. Are currently wearing daily disposable contact lenses. Have any systemic disease affecting ocular health. Are using any systemic or topical medications that will affect ocular health. Have any ocular pathology or abnormality that would affect the wearing of contact lenses. Have any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. Are aphakic. Have undergone corneal refractive surgery. Are participating in any other type of eye related clinical or research study. Require a change in lens power from more than 1 diopter as dictated by over-refraction with their habitual lens prescription.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Lenses<br>Participants will wear Control Lenses for 4 weeks | Device: Control Lenses (comfilcon A with current process)<br>* Daily wear lenses for 4 weeks<br>|
| Experimental: Test Lenses<br>Participants will wear Test Lenses for 4 weeks | Device: Test Lenses (comfilcon A with novel process)<br>* Daily wear lenses for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Monocular distance logMAR visual acuity will be measured at distance 4 meters under high illumination, high contrast conditions | 4 weeks |