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A Multi-Center Randomized Study to Evaluate the Efficacy and Safety of an Investigational Lubricant Eye Drop

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00243711
First received: October 21, 2005
Last updated: May 27, 2011
Last verified: May 2011
History of Changes
  Purpose

The efficacy, safety and acceptability of an investigational lubricant eye drop in subjects with dry eye will be evaluated in comparison with currently-available lubricant eye drops.


Condition Intervention Phase
Dry Eye
 Drug: Carboxymethylcellulose sodium and Glycerin
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Dry Eye Symptoms

Secondary Outcome Measures:
  • Ocular surface damage, tear stability, tear production

Enrollment: 286
Study Start Date: September 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Mild, Moderate, or Severe Dry Eye Symptoms and current eye drop use;
  • Reduced tear stability or tear production

Exclusion Criteria:

  • NONE
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243711

Locations
United States, Missouri
Warrensburg, Missouri, United States
Sponsors and Collaborators
Allergan
Investigators
Principal Investigator: Mark Curtis, O.D. InSight Eyecare
  More Information

No publications provided

Responsible Party: Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier: NCT00243711     History of Changes
Other Study ID Numbers: AG9689-001
Study First Received: October 21, 2005
Last Updated: May 27, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carboxymethylcellulose Sodium
Glycerol
Laxatives
Gastrointestinal Agents
Therapeutic Uses
 Pharmacologic Actions
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013