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

Bausch + Lomb

Status

Completed

Conditions

Myopia

Treatments

Device: Bausch & Lomb Test lens

Device: Ciba Vision soft contact lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT01412983

713E

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.