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

March 13, 2013 updated by: Bausch & Lomb Incorporated

Efficacy and Safety of Ecabet Ophthalmic Solution (2.83% and 3.70%) for Treatment of Dry Eye Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Lewiston, Maine, United States, 04240
        • Central Maine Eye Care
    • Massachusetts
      • Andover, Massachusetts, United States, 01840
        • Andover Eye Associates
    • New Hampshire
      • Dover, New Hampshire, United States, 03820
        • Eyesight Ophthalmic Services, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ecabet 2.83%
Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.
Drug: Ecabet 2.83%
Experimental: Ecabet 3.70%
Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.
Drug: Ecabet 3.70%
Placebo Comparator: Vehicle
One drop of vehicle in study eye 4 times daily for 90 days.
Drug: Vehicle

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

March 14, 2013

Last Update Submitted That Met QC Criteria

March 13, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISTA-ECBT-CS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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