Clinical Comparison of Two Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study is to compare the clinical performance of PRECISION1™ contact lenses to Clariti® 1 day contact lenses.

Detailed Description
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Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day. On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours. The total duration of subject participation will be up to 22 days.

Official Title
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Clinical Comparison of Two Daily Disposable Contact Lenses

Conditions
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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 Successful wearer of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. Possess spectacles and willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed. Willing to wear contact lenses for at least 16 hours on one of the days (day prior to each week 1 visit). Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers. Any monovision and multifocal lens wearers. 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 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 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 |
| --- | --- | --- |
| Least Squares Mean 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. | Day 8, 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, Disposable