NCT01412983CompletedNot Applicable
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Bausch & Lomb Incorporated1 site in 1 country100 target enrollmentStarted: August 1, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 100
- 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 investigational contact lenses developed by Bausch + Lomb.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Screening
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than grade 1 and/or presence of infiltrates).
- •Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- •Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- •Be myopic and require lens correction from -0.50 to -6.00 diopters (D) in each eye.
Exclusion Criteria
- •An active ocular disease, any corneal infiltrative response or are using any ocular medications.
- •Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
- •Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Any scar or neovascularization within the central 4mm of the cornea.
- •Have had any corneal surgery.
- •Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Any systemic disease affecting ocular health.
- •Using any systemic or topical medications that will affect ocular physiology or lens performance.
- •Currently wear monovision, multifocal, or toric contact lenses.
- •Allergic to any component in the study care products.
Arms & Interventions
Bausch & Lomb Test Lens
Experimental
Bausch + Lomb investigational soft contact lens
Intervention: Bausch & Lomb Test lens (Device)
Ciba Vision soft contact lens
Active Comparator
Ciba Vision Air Optix Aqua soft contact lens
Intervention: Ciba Vision soft contact lens (Device)
Outcomes
Primary Outcomes
Visual Acuity
Time Frame: One week
The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.
Secondary Outcomes
- Overall Comfort(One week)
Investigators
Study Sites (1)
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