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Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease

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.
ClinicalTrials.gov Identifier: NCT00667004
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : January 8, 2013
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
Efficacy study of ecabet ophthalmic solution in dry eye disease

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: ecabet ophthalmic solution Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2008
Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
ecabet ophthalmic solution
Drug: ecabet ophthalmic solution
sterile ophthalmic solution
Placebo Comparator: 2
Placebo comparator
Drug: placebo
sterile ophthalmic solution

Primary Outcome Measures :
  1. Lacrimation assessed by Schirmer's test [ Time Frame: 6 weeks ]

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:

  • Diagnosed with dry eye disease

Exclusion Criteria:

  • Dry eye disease secondary to surgery

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): 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.

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00667004     History of Changes
Other Study ID Numbers: CL-S&E-1107071-P
First Posted: April 25, 2008    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival 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