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

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: NCT00243711
Recruitment Status : Completed
First Posted : October 25, 2005
Last Update Posted : May 30, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Drug: Carboxymethylcellulose sodium and Glycerin Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : September 2005
Primary Completion Date : April 2006
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Dry Eye Symptoms

Secondary Outcome Measures :
  1. Ocular surface damage, tear stability, tear production

Eligibility Criteria

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
Criteria

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

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): NCT00243711


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

Responsible Party: Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier: NCT00243711     History of Changes
Other Study ID Numbers: AG9689-001
First Posted: October 25, 2005    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Lubricant Eye Drops
Carboxymethylcellulose Sodium
Ophthalmic Solutions
Pharmaceutical Solutions
Laxatives
Gastrointestinal Agents