The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
- Conditions
- Refractive Ametropia
- Registration Number
- NCT05766787
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.
- Detailed Description
In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
- Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- Best Corrected Visual Acuity (BCVA) of 20/25 Snellen (0.10 logMAR) or better in each eye.
- Willing to stop wearing habitual contact lenses for the duration of study participation.
- Other protocol-specific inclusion criteria may apply.
- Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.
- Habitual wear of AOHP contact lenses.
- Habitual wear of any daily disposable contact lenses.
- Other protocol-specified exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Least Squares Mean Distance VA With Study Lenses at Week 1 Week 1 of each lens product worn during the corresponding crossover period Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range 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 acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Kurata Eyecare Center
🇺🇸Los Angeles, California, United States
Dr. Elsa Pao, OD
🇺🇸Oakland, California, United States
Pacific Rims Optometry
🇺🇸San Francisco, California, United States
Omega Vision Center P.A.
🇺🇸Longwood, Florida, United States
Kindred Optics at Maitland Vision
🇺🇸Maitland, Florida, United States
Vision Health Institute
🇺🇸Orlando, Florida, United States
Tallahassee Eye Center
🇺🇸Tallahassee, Florida, United States
Heart of America Eye Care
🇺🇸Shawnee Mission, Kansas, United States
The Eye Doctors Inc
🇺🇸Eden Prairie, Minnesota, United States
Complete Eye Care of Medina
🇺🇸Medina, Minnesota, United States
Scroll for more (5 remaining)Kurata Eyecare Center🇺🇸Los Angeles, California, United States