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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ecabet 2.83%

Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.

Group Type EXPERIMENTAL

Ecabet 2.83%

Intervention Type DRUG

Ecabet 3.70%

Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.

Group Type EXPERIMENTAL

Ecabet 3.70%

Intervention Type DRUG

Vehicle

One drop of vehicle in study eye 4 times daily for 90 days.

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Interventions

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Ecabet 2.83%

Intervention Type DRUG

Ecabet 3.70%

Intervention Type DRUG

Vehicle

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No