Product Performance of a Daily Disposable Contact Lens

Bausch + Lomb

Status

Completed

Conditions

Myopia

Treatments

Device: Daily disposable cosmetic tint lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT01230554

654

Details and patient eligibility

About

The objective of this one week, single group, bilateral, open-label study is to evaluate the product performance of the Bausch & Lomb daily disposable cosmetic tint contact lens (Test) when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted soft contact lens.

Enrollment

212 patients

Sex

Female

Ages

15 to 38 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects must be females of Chinese descent and of legal age and no older than 38. OR subjects that are females of Chinese descent and are at least 15 years of age and less than the legal age must: have a parent/legal guardian provide informed consent.
Subjects must have clear central corneas and be free of any anterior segment disorders.
Subjects must be adapted current wearers of marketed opaque tinted soft contact lenses, wear their lenses two days or more per week, and wear a lens in each eye.

Exclusion criteria

Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or have worn polymethylmethacrylate (PMMA) lenses within the last three months.
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 scar or neovascularization within the central 4 mm of the cornea.
Subjects who are aphakic or amblyopic.
Subjects who have had any corneal surgery (eg, refractive surgery).
Subjects who currently wear monovision, multifocal, or toric contact lenses.