Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
- Conditions
- Myopia
- Registration Number
- NCT04476784
- Lead Sponsor
- Alcon Research
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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.
Key
- Current or prior Biofinity contact lens wearer in the past 3 months;
- Monovision contact lens wearer;
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Mean Distance Visual Acuity (logMAR) With Study Lenses 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Alcon Investigative Site
🇺🇸Memphis, Tennessee, United States
Alcon Investigative Site🇺🇸Memphis, Tennessee, United States