NCT01309906CompletedNot Applicable
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Bausch & Lomb Incorporated1 site in 1 country66 target enrollmentStarted: December 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Visual Acuity
Study Overview
Brief Summary
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of an investigational contact lens.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- •Be myopic and require lens correction in each eye.
- •Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Exclusion Criteria
- •Any systemic disease affecting ocular health.
- •Using any systemic or topical medications that will affect ocular physiology or lens performance.
- •An active ocular disease, any corneal infiltrative response or are using any ocular medications.
- •Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Allergic to any component in the study care products.
Arms & Interventions
Investigational lens
Experimental
Bausch & Lomb investigational silicone hydrogel lens
Intervention: Investigational lens (Device)
Air Optix Aqua lens
Active Comparator
Ciba Vision Air Optix Aqua contact lens
Intervention: Air Optix Aqua lens (Device)
Outcomes
Primary Outcomes
Visual Acuity
Time Frame: At 1 week follow up
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Secondary Outcomes
- Symptoms and Complaints(At 1 week follow up)
- Percentage of Eyes With > Grade 2 Slit Lamp Findings(At 1 week follow up)
Investigators
Study Sites (1)
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