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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00370747
First received: August 30, 2006
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ecabet Ophthalmic Solution for the Treatment of Dry Eye Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Ocular signs and Symptoms [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00370747     History of Changes
Other Study ID Numbers: ISTA-ECBT-CS02
Study First Received: August 30, 2006
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Ecabet
Anti-Ulcer Agents
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 23, 2013