Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractive Errors
- Sponsor
- Alcon Research
- Enrollment
- 68
- Locations
- 5
- Primary Endpoint
- Visual Acuity With Study Lenses at Week 1 Follow-Up
- Status
- Completed
- Last Updated
- 2 years ago
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 study lens type for approximately 14 days and attend 7 scheduled visits. The expected duration of subject participation in the study is approximately 28 days (approximately 14 days per each study lens type).
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 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-specified 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
Visual Acuity With Study Lenses at Week 1 Follow-Up
Time Frame: Week 1, each wear period. A wear period was approximately 14 days.
Visual acuity (VA) was assessed with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. Each eye was assessed individually. No hypothesis testing was pre-specified for this endpoint.