Study to Evaluate a Contact Lens Lubricating and Rewetting Drop

Not Applicable

Completed

• Conditions: Dry Eye

• Registration Number: NCT01267656
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2010-12-27
• Study First Submitted QC: 2010-12-27
• Study First Posted: 2010-12-28
• Results First Submitted: 2020-08-21
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-29
• Last Update Submitted: 2020-09-29
• Results First Posted: 2020-09-30
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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.
• Aphakic.
• Amblyopic.
• Allergic to any component in the study care products.
• Have had any corneal surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Trial Locations

Locations (1)

Bausch & Lomb; 🇺🇸 Rochester, New York, United States