Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

Study Overview
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Brief Summary
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The purpose of this study is to evaluate end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses.

Detailed Description
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The expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (Screening, Dispense, Exit).

Official Title
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Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

Conditions
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Refractive Errors

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and sign an approved Informed Consent form Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day Best corrected VA of logMAR 0.10 or better in each eye Willing to discontinue artificial tears and rewetting drops during the study Able to wear contact lenses within the protocol-specified sphere power range Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Any anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator History of ocular or intraocular surgery, including refractive surgery, and/or irregular cornea Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment Previous 3 years or current wearers of Acuvue Moist 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: Parallel Assignment
Interventional Model Description: Contralateral
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Verofilcon A contact lens in the right eye (OD), with etafilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours. | Device: Verofilcon A contact lenses<br>* Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)<br>* Other names: Precision1™;Device: Etafilcon A contact lenses<br>* Daily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)<br>* Other names: Acuvue® Moist;|
| Active Comparator: Sequence 2<br>Etafilcon A contact lens in the right eye (OD), with verofilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours. | Device: Verofilcon A contact lenses<br>* Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)<br>* Other names: Precision1™;Device: Etafilcon A contact lenses<br>* Daily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)<br>* Other names: Acuvue® Moist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of day (EOD) visual acuity at distance | Visual acuity (VA) will be measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity. | Day 1, after 8 hours of wear | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lens, Vision correction, Visual acuity, Daily disposable contact lens