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
  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:


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
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 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 July 28, 2014