A Study to Evaluate the Safety and Efficacy of a Novel Contact Lens for Daily Disposable Use
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 173
- Locations
- 1
- Primary Endpoint
- Slit Lamp Findings > Grade 2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Test lens
Test contact lens will be worn on a daily disposable wear basis.
Intervention: Test, daily disposable contact lens (Device)
SofLens lens
The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.
Intervention: SofLens daily disposable contact lens (Device)
Outcomes
Primary Outcomes
Slit Lamp Findings > Grade 2
Time Frame: 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)
Time Frame: 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 Outcomes
No secondary outcomes reported