Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses

Study Overview
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Brief Summary
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The primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT).

Detailed Description
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Study participants will wear each study lens type in 1 of 2 randomized, crossover sequences. Participants will be expected to attend 4 visits and wear study lenses for at least 10 hours per day. The total duration of an individual's participation in the study will be up to 28 days.

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

Conditions
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Astigmatism, Ametropia, Myopia

Intervention / Treatment
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* Device: Verofilcon A toric soft contact lenses
* Device: Stenfilcon A toric soft contact lenses


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Successful wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. Able to wear contact lenses within a range of sphere & cylinder power and axes. Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Current or previous P1fA and MDT habitual lens wearers. Monovision and multifocal lens wearers. Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial. 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: P1fA, then MDT<br>Verofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use. | Device: Verofilcon A toric soft contact lenses<br>* Soft contact lenses for optical correction of ametropia and astigmatism<br>* Other names: P1fA;Device: Stenfilcon A toric soft contact lenses<br>* Soft contact lenses for optical correction of ametropia and astigmatism<br>* Other names: MDT;|
| Other: MDT, then P1fA<br>Stenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use. | Device: Verofilcon A toric soft contact lenses<br>* Soft contact lenses for optical correction of ametropia and astigmatism<br>* Other names: P1fA;Device: Stenfilcon A toric soft contact lenses<br>* Soft contact lenses for optical correction of ametropia and astigmatism<br>* Other names: MDT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Means Distance Visual Acuity With Study Lenses at Week 1 | 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. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity. | Day 8 of each study lens type worn during the corresponding crossover period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lenses, Vision, Eye sight