A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens

Bausch & Lomb Incorporated1 site in 1 country100 target enrollmentAugust 2011

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Bausch & Lomb Incorporated
Enrollment: 100
Locations: 1
Primary Endpoint: Visual Acuity
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

October 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

Eligibility Criteria

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.