Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Alcon Research
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Mean Distance Visual Acuity (logMAR) With Study Lenses
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.
Detailed Description
Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 60 days (30 days for each product).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to understand and sign an approved Informed Consent form;
- •Willing and able to attend all scheduled study visits as required by the protocol;
- •Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Current or prior Biofinity contact lens wearer in the past 3 months;
- •Monovision contact lens wearer;
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Mean Distance Visual Acuity (logMAR) With Study Lenses
Time Frame: Day 1, Day 30 after 6-8 hours of wear, each product
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.