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

Bausch & Lomb Incorporated0 sites166 target enrollmentAugust 2011

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Bausch & Lomb Incorporated
Enrollment: 166
Primary Endpoint: Visual Acuity (VA)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

January 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Visual Acuity (VA)

Time Frame: 4 visits over 3 months

Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months.