Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

Study Overview
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Brief Summary
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The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.

Official Title
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Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

Conditions
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Refractive Error

Intervention / Treatment
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* Device: FID122819 contact lenses
* Device: Stenfilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and sign an IRB-approved Informed Consent Form; Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months: Manifest cylinder of ≤ 0.75 diopter (D) in each eye; Best corrected visual acuity (BCVA) of 20/25 or better in each eye; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator; Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator; History of refractive surgery or plan to have refractive surgery during the study; Ocular or intraocular surgery within the previous 12 months or planned during the study; Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear; Any previous or current wear of MYDAY; Habitually wearing monovision or multifocal lenses during the last 3 months; Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment; Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear; Other protocol-defined exclusion criteria may apply.

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FID122819, then stenfilcon A<br>FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week | Device: FID122819 contact lenses<br>* Investigational spherical silicone hydrogel contact lenses for daily disposable wear<br>* Other names: Verofilcon A;Device: Stenfilcon A contact lenses<br>* Commercially available spherical silicone hydrogel contact lenses for daily disposable wear<br>* Other names: MyDay®;|
| Other: Stenfilcon A, then FID122819<br>Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week | Device: FID122819 contact lenses<br>* Investigational spherical silicone hydrogel contact lenses for daily disposable wear<br>* Other names: Verofilcon A;Device: Stenfilcon A contact lenses<br>* Commercially available spherical silicone hydrogel contact lenses for daily disposable wear<br>* Other names: MyDay®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity (VA) | VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis. | Baseline/Dispense (Day 1), Week 1, each product | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lens, silicone hydrogel, daily disposable, visual acuity