Study to Evaluate the Product Feasibility of a Contact Lens Lubricating and Rewetting Drop

Bausch & Lomb Incorporated1 site in 1 country168 target enrollmentOctober 2010

ConditionsDry Eye

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dry Eye
Sponsor: Bausch & Lomb Incorporated
Enrollment: 168
Locations: 1
Primary Endpoint: Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

December 2010

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
•Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
•Use a lens care system on a regular basis.
•Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day.
•Willing to use drops 4 times per day.

Exclusion Criteria

•Participating in a conflicting study.
•An active ocular disease, any corneal infiltrative response, or are using any ocular medications.
•Any scar or neovascularization within the central 4mm of the cornea.
•Any grade 2 or greater finding during the slit lamp examination
•Using any systemic or topical medications that will affect ocular physiology or lens performance.
•Amblyopic.
•Allergic to any component in the study care products.
•Have had any corneal surgery.

Outcomes

Primary Outcomes

Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.

Time Frame: At 1 week follow up

Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding \> grade 2, across abnormalities.