Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.

Detailed Description
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The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.

Official Title
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Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

Conditions
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Myopia, Ametropia

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


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board. Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Current/previous PRECISION1 or INFUSE contact lens wearer. Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator. Routinely sleeps in contact lenses. 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
Interventional Model Description: Subjects will receive treatment based upon the randomized treatment sequence assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Precision1, then Infuse<br>Verofilcon A contact lenses worn first, with kalifilcon 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>* Commercially available silicone hydrogel contact lenses for daily disposable wear<br>* Other names: PRECISION1™;Device: Kalifilcon A contact lenses<br>* Commercially available silicone hydrogel contact lenses for daily disposable wear<br>* Other names: Bausch + Lomb INFUSE™;|
| Other: Infuse, then Precision1<br>Kalifilcon 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>* Commercially available silicone hydrogel contact lenses for daily disposable wear<br>* Other names: PRECISION1™;Device: Kalifilcon A contact lenses<br>* Commercially available silicone hydrogel contact lenses for daily disposable wear<br>* Other names: Bausch + Lomb INFUSE™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance VA (logMAR) With Study Lenses | Distance visual acuity (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 inferential testing was pre-specified for this endpoint. | Day 8 (-0/+3 days), each study lens type | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lenses