Safety and Efficacy of a Contact Lens for Daily Disposable Use
Not Applicable
Completed
- Conditions
- Myopia
- Interventions
- Device: Test, daily disposable contact lensDevice: SofLens daily disposable contact lens
- Registration Number
- NCT01365039
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
Inclusion Criteria
- Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye.
- Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye.
- Subjects must be free of any anterior segment disorders.
- Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.
Exclusion Criteria
- Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
- Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Subjects who have had any corneal surgery (eg, refractive surgery).
- Subjects who are allergic to any component in the study care products.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test lens Test, daily disposable contact lens Test contact lens will be worn on a daily disposable wear basis. SofLens lens SofLens daily disposable contact lens The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.
- Primary Outcome Measures
Name Time Method Slit Lamp Findings > Grade 2 4 visits over 3 months Statistical non-inferiority of Slit Lamp Findings \> Grade 2 at any visit between the Test and Control lenses
High Contrast, Distance logMAR Visual Acuity (VA) 4 visits over 3 months Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bausch & Lomb, Inc.
🇺🇸Rochester, New York, United States