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

Bausch & Lomb Incorporated1 site in 1 country144 target enrollmentNovember 2010

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Bausch & Lomb Incorporated
Enrollment: 144
Locations: 1
Primary Endpoint: Visual Acuity (Investigational vs Air Optix Aqua Lens)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

January 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

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 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 myopic and require lens correction

Exclusion Criteria

•Subjects with 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.

Outcomes

Primary Outcomes

Visual Acuity (Investigational vs Air Optix Aqua Lens)

Time Frame: 1 week

The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.

Visual Acuity (Investigational vs Acuvue Oasys Lens)

Time Frame: 1 week

The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.