Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease

This study has been completed.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
First received: April 23, 2008
Last updated: January 3, 2013
Last verified: January 2013
Efficacy study of ecabet ophthalmic solution in dry eye disease

Condition Intervention Phase
Dry Eye Disease
Drug: ecabet ophthalmic solution
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Lacrimation assessed by Schirmer's test [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: April 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ecabet ophthalmic solution
Drug: ecabet ophthalmic solution
sterile ophthalmic solution
Placebo Comparator: 2
Placebo comparator
Drug: placebo
sterile ophthalmic solution


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with dry eye disease

Exclusion Criteria:

  • Dry eye disease secondary to surgery
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00667004

United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
  More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00667004     History of Changes
Other Study ID Numbers: CL-S&E-1107071-P 
Study First Received: April 23, 2008
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Infective Agents
Anti-Ulcer Agents
Anticarcinogenic Agents
Antineoplastic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protease Inhibitors
Protective Agents

ClinicalTrials.gov processed this record on May 25, 2016