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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370747
First Posted: September 1, 2006
Last Update Posted: March 15, 2013
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.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  Purpose
The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome

Condition Intervention Phase
Dry Eye Syndromes Drug: Ecabet Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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:
  • Ocular Surface Disease Index (OSDI) [ Time Frame: 90 days ]
    Questionaire


Estimated Enrollment: 162
Study Start Date: September 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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): NCT00370747


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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00370747     History of Changes
Other Study ID Numbers: ISTA-ECBT-CS02
First Submitted: August 30, 2006
First Posted: September 1, 2006
Last Update Posted: March 15, 2013
Last Verified: March 2013

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