Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens

Study Overview
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Brief Summary
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The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.

Detailed Description
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The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.

Official Title
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Comparison of Daily Disposable Invigor I (Test) and Select 1 Day Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: somofilcon A 1 day test lens
* Device: somofilcon A 1 day control lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer; Has had a self-reported oculo-visual examination in the last two years; Has read, understood, and signed the information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity); Must be able to achieve 20/30 or better (in each eye) with the study lenses; Currently wears soft contact lenses for at least 3 days per week, 8 hours each day; Requires spectacle lens powers between -0.75 and -06.50 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. 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 enrolment (by verbal confirmation at the screening visit).

Ages Eligible for Study
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Minimum Age: 17 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: somofilcon A 1 day test lens<br>Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. | Device: somofilcon A 1 day test lens<br>* Contact lens<br>* Other names: Test lens;Device: somofilcon A 1 day control lens<br>* Contact lens<br>* Other names: Control lens;|
| Active Comparator: somofilcon A 1 day control lens<br>Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. | Device: somofilcon A 1 day test lens<br>* Contact lens<br>* Other names: Test lens;Device: somofilcon A 1 day control lens<br>* Contact lens<br>* Other names: Control lens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever) | up to 1 week | 
| Preference | Overall lens that subject prefers or no preference | up to 1 week | 
| Vision | Visual acuity measured in logMAR | Up to 1 week | 
| Subjective Vision | Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time) | up to 1 week | 
| Corneal Staining | Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps | up to 1 week | 
| Conjunctival Staining | Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps | up to 1 week |