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

This study has been completed.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated Identifier:
First received: August 30, 2006
Last updated: March 13, 2013
Last verified: March 2013
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 ]

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


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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00370747

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

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00370747     History of Changes
Other Study ID Numbers: ISTA-ECBT-CS02
Study First Received: August 30, 2006
Last Updated: March 13, 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 processed this record on August 18, 2017