A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

Bausch + Lomb

Status

Completed

Conditions

Myopia

Treatments

Device: B&L Investigational Contact Lens

Device: B&L PureVision Contact Lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT01449526

661

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens wearers.

Enrollment

166 patients

Sex

All

Ages

18 to 40 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 myopic, and wear contact lenses in each eye.
Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.

Exclusion criteria

Subjects who are older than age 40 on the date the informed consent (ICF) is signed.
Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
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 who are using any ocular medication.
Subjects with any grade 2 or greater finding during the slit lamp examination.
Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Subjects who are allergic to any component in the study care products.