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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Glycerol Carboxymethylcellulose

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score [ Time Frame: Change from baseline at Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline at Day 30 in Schirmer Test, With Anesthesia [ Time Frame: Change from baseline at Day 30 ] [ Designated as safety issue: No ]
Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein [ Time Frame: Change from baseline at Day 30 ] [ Designated as safety issue: No ]
Patient Acceptability Score (Dryness) at Day 30 [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Patient Acceptability Score (Vision) at Day 30 [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein [ Time Frame: Change from baseline at Day 30 ] [ Designated as safety issue: No ]
Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein [ Time Frame: Change from baseline at Day 30 ] [ Designated as safety issue: No ]
Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score [ Time Frame: Change from baseline at Day 30 ] [ Designated as safety issue: No ]

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
Experimental: 1 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
Active Comparator: 2 Carboxymethylcellulose	Drug: Carboxymethylcellulose 1 to 2 drops into each eye as needed but at least twice daily Other Name: Refresh Plus

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 Symptoms of Dry Eye

Exclusion Criteria:

Uncontrolled systemic disease
Use of systemic medications affecting dry eye
Pregnancy or planning a pregnancy
Contact lens wear

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

No publications provided

Responsible Party:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00514852 History of Changes
Other Study ID Numbers:	AG9818-002
Study First Received:	August 8, 2007
Results First Received:	May 19, 2009
Last Updated:	November 10, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

Carboxymethylcellulose Sodium
Glycerol
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012