Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1

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 Biotrue ONEday contact lenses.

Detailed Description
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Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday 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 1

Conditions
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Refractive Errors, Myopia

Intervention / Treatment
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* Device: Verofilcon A contact lenses
* Device: Nesofilcon 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 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. 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, Biotrue ONEday, 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 Biotrue ONEday<br>Verofilcon A contact lenses worn first, with nesofilcon 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: Nesofilcon A contact lenses<br>* Spherical soft contact lenses for daily disposable wear<br>* Other names: Bausch + Lomb Biotrue® ONEday;|
| Other: Biotrue ONEday, then PRECISION1<br>Nesofilcon 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: Nesofilcon A contact lenses<br>* Spherical soft contact lenses for daily disposable wear<br>* Other names: Bausch + Lomb Biotrue® ONEday;|

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