Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses

Not Applicable

Completed

Interventions: Device: Verofilcon A toric soft contact lenses
Device: Stenfilcon A toric soft contact lenses

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
P1fA, then MDT	Verofilcon A toric soft contact lenses	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.
MDT, then P1fA	Stenfilcon A toric soft contact lenses	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.
P1fA, then MDT	Stenfilcon A toric soft contact lenses	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.
MDT, then P1fA	Verofilcon A toric soft contact lenses	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.

Primary Outcome Measures

Name	Time	Method
Least Squares Means Distance Visual Acuity With Study Lenses at Week 1	Day 8 of each study lens type worn during the corresponding crossover period	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.

Secondary Outcome Measures

Name	Time	Method

Locations (11): Heart of America Eye Care, P.A.
🇺🇸
Shawnee Mission, Kansas, United States
Kannarr Eye Care
🇺🇸
Pittsburg, Kansas, United States
Drs. Giedd, P.A.
🇺🇸
Maitland, Florida, United States
Optometry Group, PLLC
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Memphis, Tennessee, United States
Sabal Eye Care
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Longwood, Florida, United States
Vision Health Institute
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Orlando, Florida, United States
Kurata Eyecare Center
🇺🇸
Los Angeles, California, United States
Franklin Park Eye Center
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Franklin Park, Illinois, United States
ProCare Vision Center
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Granville, Ohio, United States
Wesley Optometric Consulting
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Medina, Minnesota, United States
West Bay Eye Associates
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Warwick, Rhode Island, United States