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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. Identifier: NCT00370747
Recruitment Status : Completed
First Posted : September 1, 2006
Last Update Posted : March 15, 2013
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 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ecabet Ophthalmic Solution for the Treatment of Dry Eye Syndrome
Study Start Date : September 2006
Primary Completion Date : June 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ecabet
Ophthalmic solution in the Study eye four times daily for 90 days.
Drug: Ecabet
ophthalmic solution 2.83%
Drug: Ecabet
ophthalmic solution 3.70%
Placebo Comparator: Placebo
Ophthalmic solution in the Study eye four times daily for 90 days.
Drug: Placebo

Primary Outcome Measures :
  1. Ocular signs and Symptoms [ Time Frame: 90 days ]
    ocular signs, including corneal and conjunctival staining, tear film breakup time and blink rate, and ocular symptoms, including burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness, photophobia, photopsia, and eye discomfort

Secondary Outcome Measures :
  1. Ocular Surface Disease Index (OSDI) [ Time Frame: 90 days ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male/female at least 18 years of age
  • Agree to avoid disallowed medications
  • Have a diagnosis of dry eye

Exclusion Criteria:

  • Have chronic systemic inflammation
  • Have active seasonal ocular allergies

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 identifier (NCT number): NCT00370747

United States, California
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Study Director: Ralph Bianca, PhD ISTA Pharmaceuticals, Inc.

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00370747     History of Changes
Other Study ID Numbers: ISTA-ECBT-CS02
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
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