A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses

Bausch & Lomb Incorporated1 site in 1 country216 target enrollmentApril 2012

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Bausch & Lomb Incorporated
Enrollment: 216
Locations: 1
Primary Endpoint: Visual Acuity
Status: Completed
Last Updated: 5 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 two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

July 2012

Last Updated

5 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.
•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 diopters (D) to -6.00 D in each eye.
•Must agree to wear the study lenses on a daily wear basis for the duration of the study.
•Must be willing to use a lens care system on a regular basis.
•If the subject requires a Washout Period, the subject must be willing to discontinue contact lens wear and be willing to wear either spectacles or no lenses during this Washout Period.

Exclusion Criteria

•Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
•Have 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 scar or neovascularization within the central 4mm of the cornea.
•Any Grade 2 or greater finding during the slit lamp examination, Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
•Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
•Anisometropia (spherical equivalent) of greater than 2.00 D.
•Any systemic disease affecting ocular health.
•Using any systemic or topical medications that will affect ocular physiology or lens performance.
•Amblyopic.