Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 2

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Clariti 1-Day contact lenses.

Detailed Description
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Subjects are expected to attend 3 study visits and wear the PRECISION1 and Clariti 1-Day study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.

Official Title
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Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 2

Conditions
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Myopia, Refractive Errors

Intervention / Treatment
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* Device: Verofilcon A contact lenses
* Device: Somofilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form. Successful wear of soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type. Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Any ocular condition that contraindicates contact lens wear. Previous or current habitual wearer of PRECISION1, Clariti 1-Day, or DAILIES TOTAL1 contact lenses. Other protocol-specified 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: PRECISION1, then Clariti 1-Day<br>Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. | Device: Verofilcon A contact lenses<br>* Spherical soft contact lenses for daily disposable wear<br>* Other names: PRECISION1™;Device: Somofilcon A contact lenses<br>* Spherical soft contact lenses for daily disposable wear<br>* Other names: Clariti 1-Day;|
| Other: Clariti 1-Day, then PRECISION1<br>Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. | Device: Verofilcon A contact lenses<br>* Spherical soft contact lenses for daily disposable wear<br>* Other names: PRECISION1™;Device: Somofilcon A contact lenses<br>* Spherical soft contact lenses for daily disposable wear<br>* Other names: Clariti 1-Day;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity (VA) With Study Lenses | Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed. | Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Daily disposable contact lenses