A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Not Applicable
Completed
- Conditions
- Myopia
- Interventions
- Device: Bausch & Lomb Test lensDevice: Ciba Vision soft contact lens
- Registration Number
- NCT01412983
- Lead Sponsor
- Bausch & Lomb Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Bausch & Lomb Test Lens Bausch & Lomb Test lens Bausch + Lomb investigational soft contact lens Ciba Vision soft contact lens Ciba Vision soft contact lens Ciba Vision Air Optix Aqua soft contact lens
- Primary Outcome Measures
Name Time Method Visual Acuity One week The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.
- Secondary Outcome Measures
Name Time Method Overall Comfort One week The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.
Trial Locations
- Locations (1)
Bausch & Lomb Incorporated
🇺🇸Rochester, New York, United States