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Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
This study has been completed.
First Received: August 8, 2007   Last Updated: May 28, 2008   History of Changes
Sponsored by: 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: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Drug Information available for: Carboxymethylcellulose
U.S. FDA Resources

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:
  • Schirmer Test [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Tear Break-Up Time [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Staining [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Patient Acceptability [ Time Frame: 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
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

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: Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers: AG9818-002
Study First Received: August 8, 2007
Last Updated: May 28, 2008
ClinicalTrials.gov Identifier: NCT00514852     History of Changes
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
Eye Diseases
 Syndrome
Lacrimal Apparatus Diseases
Dry Eye Syndromes

ClinicalTrials.gov processed this record on September 04, 2009



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