Status:
COMPLETED
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Myopia
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01412983
Start Date
August 1 2011
End Date
October 1 2011
Last Update
April 29 2014
Active Locations (1)
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1
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609