A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon A (control).

Detailed Description
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The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 1 week compared to nelfilcon A (control). The primary outcomes of interest is lens fit acceptance.

Official Title
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A One-Week Crossover Dispensing Evaluation of Gemini Daily Wear Soft Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Test Contact Lens
* Device: Nelfilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 18 years of age and has full legal capacity to volunteer. Is no greater than 55 years of age. Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule. Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study. Has spectacle cylinder ≤1.00D in both eyes. Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes. Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye. Wears CLs in both eyes (monvision acceptable, but not monofit) Has clear corneas and no active ocular disease. Has not worn lenses for at least 12 hours before the examination. Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week Exclusion Criteria: Has never worn contact lenses before. Has any systemic disease affecting ocular health. Is using any systemic or topical medications that will affect ocular health. Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. Is aphakic. Has strabismus/amblyopia. Has undergone corneal refractive surgery. Is pregnant, lactating or planning a pregnancy. Is participating in any concurrent clinical or research study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Interventional Model Description: This will be a double-masked, bilateral, 1-week crossover, dispensing study, comparing the test daily wear lens against nelfilcon A control lens, such that each lens type will be worn for 1 week each. Each subject will be randomized to wear either the test lenses or the control lenses as a matched pair.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Contact Lens<br>Per randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week. | Device: Test Contact Lens<br>* Daily disposable contact lens<br>Device: Nelfilcon A<br>* Focus Dailies All Day Comfort contact lens (nelfilcon A)<br>|
| Active Comparator: nelfilcon A lens (control)<br>Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week. | Device: Test Contact Lens<br>* Daily disposable contact lens<br>Device: Nelfilcon A<br>* Focus Dailies All Day Comfort contact lens (nelfilcon A)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum) | Baseline | 
| Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum) | 1-Week |