A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens

Bausch + Lomb

Status

Completed

Conditions

Myopia

Treatments

Device: Bausch & Lomb contact lens

Device: Marketed daily disposable contact lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT01130974

639

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy of the Bausch & Lomb daily disposable tint contact lens (Test) compared to a currently marketed daily disposable cosmetic tint contact lens (Control).

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must have clear central corneas and be free of any anterior segment disorders.
Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
Subjects must be of Asian descent.
Subjects must require plano or myopic correction and must require contact lens correction from plano to -6.00 D in both eyes.

Exclusion criteria

Subjects who have any systemic disease affecting ocular health.
Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
Subjects with an active ocular disease or are using any ocular medication.
Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
Subjects who currently wear monovision, multifocal, or toric contact lenses.
Subjects who are adapted wearers of 1-Day Acuvue Define daily disposable cosmetic tint contact lenses.