Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00667004
First received: April 23, 2008
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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

  Eligibility

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

Inclusion Criteria:

  • Diagnosed with dry eye disease

Exclusion Criteria:

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

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

No publications provided

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:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus 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 April 14, 2014