Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Astigmatism
- Sponsor
- Alcon Research
- Enrollment
- 153
- Locations
- 11
- Primary Endpoint
- Least Squares Means Distance Visual Acuity With Study Lenses at Week 1
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Least Squares Means Distance Visual Acuity With Study Lenses at Week 1
Time Frame: 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.