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

This study has been completed.

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00243711

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 II Phase III

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride Carboxymethylcellulose Glycerol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:

Dry Eye Symptoms

Secondary Outcome Measures:

Ocular surface damage, tear stability, tear production

Estimated Enrollment:

300

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

Study ID Numbers:	AG9689-001
Study First Received:	October 21, 2005
Last Updated:	August 24, 2006
ClinicalTrials.gov Identifier:	NCT00243711
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glycerol
Tetrahydrozoline

ClinicalTrials.gov processed this record on January 13, 2009