Clinical Performance of Two Daily Disposable Toric 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™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.

Detailed Description
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Subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. The total duration of subject participation will be up to 22 days.

Official Title
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Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses

Conditions
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Refractive Errors, Ametropia, Astigmatism

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Successful wear of toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for ASTIGMATISM contact lens wearers. Any spherical monovision and multifocal lens wearers. Routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment. 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: P1fA, then AMfA<br>Verofilcon A toric contact lenses worn first, with etafilcon A toric 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 toric contact lenses<br>* Soft contact lenses for optical correction of astigmatism<br>* Other names: P1fA;Device: Etafilcon A toric contact lenses<br>* Soft contact lenses for optical correction of astigmatism<br>* Other names: AMfA;|
| Other: AMfA, then P1fA<br>Etafilcon A toric contact lenses worn first, with verofilcon A toric 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 toric contact lenses<br>* Soft contact lenses for optical correction of astigmatism<br>* Other names: P1fA;Device: Etafilcon A toric contact lenses<br>* Soft contact lenses for optical correction of astigmatism<br>* Other names: AMfA;|

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 (-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, Disposable