Clinical Performance of Two Daily Disposable Soft 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 with Biotrue contact lenses.

Detailed Description
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Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be up to 22 days.

Official Title
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Clinical Performance of Two Daily Disposable Soft Contact Lenses

Conditions
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Refractive Errors

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: Successful wear 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. 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 the day prior to Visit 2 and the day prior to Visit 3. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial. Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear. Monovision and multifocal 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: PRECISION1, then Biotrue<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) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day. | 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: Biotrue® ONEday;|
| Other: Biotrue, 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) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day. | 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: Biotrue® ONEday;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Mean Distance Visual Acuity (VA) With Study Lenses | Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. | 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