Myopia Clinical Trial
Official title:
Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses
Verified date | October 2023 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 153 |
Est. completion date | October 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Franklin Park Eye Center | Franklin Park | Illinois |
United States | ProCare Vision Center | Granville | Ohio |
United States | Sabal Eye Care | Longwood | Florida |
United States | Kurata Eyecare Center | Los Angeles | California |
United States | Drs. Giedd, P.A. | Maitland | Florida |
United States | Wesley Optometric Consulting | Medina | Minnesota |
United States | Optometry Group, PLLC | Memphis | Tennessee |
United States | Vision Health Institute | Orlando | Florida |
United States | Kannarr Eye Care | Pittsburg | Kansas |
United States | Heart of America Eye Care, P.A. | Shawnee Mission | Kansas |
United States | West Bay Eye Associates | Warwick | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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