Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye - Full Text View

Purpose

The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear

Condition	Intervention
Dry Eye Syndrome	Drug: Carboxymethylcellulose and Glycerin based artificial tear Drug: Carboxymethylcellulose

ChemIDplus related topics:

Glycerol Carboxymethylcellulose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:

Dry eye symptoms as measured by OSDI© [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Enrollment:	316
Study Start Date:	October 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Carboxymethylcellulose and Glycerin based artificial tear	Drug: Carboxymethylcellulose and Glycerin based artificial tear 1 to 2 drops into each eye as needed but at least twice daily
2: Active Comparator Carboxymethylcellulose	Drug: Carboxymethylcellulose 1 to 2 drops into each eye as needed but at least twice daily

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514852

Locations


United States, California

	San Diego, California, United States

Sponsors and Collaborators

Allergan

Investigators


Study Director:	Medical Director	Allergan

More Information

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	AG9818-002
First Received:	August 8, 2007
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00514852
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Lacerations

Glycerol

Eye Diseases

Lacrimal Apparatus Diseases

Dry Eye Syndromes

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

ClinicalTrials.gov processed this record on August 29, 2008

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00514852