A Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens.

Study Overview
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Brief Summary
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The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.

Detailed Description
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The purpose of this study is to evaluate the clinical performance of a silicone-hydrogel test contact lens compared to the commercially available silicone-hydrogel (control) contact lens when worn over one week for each lens type in a randomized, bilateral, cross-over, dispensing study on a daily disposable basis.

Official Title
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A Dispensing Clinical Trial of Invigor 1 Daily Disposable Lens Against Clariti 1-day Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: Test lens
* Device: Control lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has had a self-reported oculo-visual examination in the last two years. Is at least 18 years of age and has full legal capacity to volunteer. Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. Currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops Requires spectacle lens spherical powers between -1.00 to -5.75 diopters sphere (0.25D steps). Has no more than 0.75 diopters of refractive astigmatism. Has clear corneas and no active ocular disease. Has not worn lenses for at least 12 hours before the examination. Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit Exclusion Criteria: Is presently participating in any other clinical or research study including eye related clinical or research study. Has never worn contact lenses before. Has any systemic disease affecting ocular health. Has any active ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health. Has any known sensitivity to fluorescein dye or products to be used in the study. 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 undergone corneal refractive surgery. Is pregnant, lactating, or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit).

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: Crossover Assignment
Interventional Model Description: This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test lens<br>Subjects wearing the test lens for one week, either randomized as the first or second pair. | Device: Test lens<br>* contact lens<br>* Other names: Somofilcon A 1 day Test;Device: Control lens<br>* contact lens<br>* Other names: Somofilcon A 1 day control;|
| Active Comparator: Control lens<br>Subjects wearing the control lens for one week, either randomized as the first or second pair. | Device: Test lens<br>* contact lens<br>* Other names: Somofilcon A 1 day Test;Device: Control lens<br>* contact lens<br>* Other names: Somofilcon A 1 day control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Lens Centration | Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I) | Baseline | 
| Number of Participants With Lens Centration | Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I) | 1 week | 
| Post Blink Movement | Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink) | Baseline | 
| Post Blink Movement | Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink) | 1 week | 
| Primary Gaze Lag | Primary Gaze Lag (measured in mm at 0.1mm steps) | baseline | 
| Primary Gaze Lag | Primary Gaze Lag (measured in mm at 0.1mm steps) | 1 week | 
| Up Gaze Lag | Up Gaze Lag (measured in mm at 0.1mm steps) | Baseline | 
| Up Gaze Lag | Up Gaze Lag (measured in mm at 0.1mm steps) | 1 week | 
| Push-Up Tightness | Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement) | baseline | 
| Push-Up Tightness | Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement) | 1 week | 
| Overall Fit Acceptance | Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum | Baseline | 
| Overall Fit Acceptance | Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum | 1 week | 
| Number of Participants With Overall Lens Fit Impression | Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable | Baseline | 
| Number of Participants With Overall Lens Fit Impression | Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Comfort Rating | Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable) | Baseline | 
| Subjective Comfort Rating | Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable) | 1-week |