Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome

Phase 2

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Ecabet 2.83%; Drug: Ecabet 3.70%; Drug: Vehicle

• Registration Number: NCT00198536
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• Agree to avoid systemic & topical ophthalmic meds & disallowed meds
• Have a best corrected visual acuity (BCVA) of 20/40 with pinhole or better in each eye
• Diagnosis of moderate dry eye syndrome

Exclusion Criteria

• Uncontrolled ocular or systemic disease that could interfere with study
• Diagnosis of Sjogren's syndrome, lacrimal obstruction, reflex, lid-related or contact lens-related dry eye syndrome(DES); significant anterior blepharitis or meibomianitis
• Contraindications or hypersensitivity to use of study meds or components
• Wear contact lenses
• Secondary dry eye to surgery
• Eye surgery (including laser) within 6 months
• Use of systemic or topical ophthalmic meds within 14 days
• Punctal plugs in one or both eyes in place for <45 days
• Permanent occlusion of the lacrimal puncta

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ecabet 2.83%	Ecabet 2.83%	Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.
Ecabet 3.70%	Ecabet 3.70%	Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.
Vehicle	Vehicle	One drop of vehicle in study eye 4 times daily for 90 days.

Primary Outcome Measures

Name	Time	Method
Ocular discomfort	Day 91	Group mean change in ocular discomfort score from pre-Cataract extraction (CAE) to post-CAE
Tear Film Break-up Time (TFBUT)	Day 91	Group mean change in time to tear break-up from pre-CAE to post-CAE.
Blink Rate	Day 91	Group mean change in blinks/min from pre-CAE to post-CAE.

Trial Locations

Locations (3)

Eyesight Ophthalmic Services, PA; 🇺🇸 Dover, New Hampshire, United States

Central Maine Eye Care; 🇺🇸 Lewiston, Maine, United States

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States