The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractive Ametropia
- Sponsor
- Alcon Research
- Enrollment
- 190
- Locations
- 15
- Primary Endpoint
- Least Squares Mean Distance VA With Study Lenses at Week 1
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Least Squares Mean Distance VA With Study Lenses at Week 1
Time Frame: 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.