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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00198536
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 14, 2013
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Ecabet 2.83% Drug: Ecabet 3.70% Drug: Vehicle Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ecabet Ophthalmic Solution (2.83% and 3.70%) for Treatment of Dry Eye Syndrome
Study Start Date : April 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

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



Primary Outcome Measures :
  1. Ocular discomfort [ Time Frame: Day 91 ]
    Group mean change in ocular discomfort score from pre-Cataract extraction (CAE) to post-CAE

  2. 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.

  3. Blink Rate [ Time Frame: Day 91 ]
    Group mean change in blinks/min from pre-CAE to post-CAE.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198536


Locations
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United States, Maine
Central Maine Eye Care
Lewiston, Maine, United States, 04240
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01840
United States, New Hampshire
Eyesight Ophthalmic Services, PA
Dover, New Hampshire, United States, 03820
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00198536    
Other Study ID Numbers: ISTA-ECBT-CS01
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ecabet
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents