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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.
Information provided by:
Allergan Identifier:
First received: October 21, 2005
Last updated: May 27, 2011
Last verified: May 2011
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
Intervention Model: Parallel Assignment
Masking: Double
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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  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 identifier: NCT00243711

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

Responsible Party: Therapeutic Area Head, Allergan, Inc Identifier: NCT00243711     History of Changes
Other Study ID Numbers: AG9689-001
Study First Received: October 21, 2005
Last Updated: May 27, 2011

Additional relevant MeSH terms:
Lubricant Eye Drops
Carboxymethylcellulose Sodium
Ophthalmic Solutions
Pharmaceutical Solutions
Gastrointestinal Agents processed this record on September 21, 2017