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Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye

This study has been completed.
Study NCT00514852.   Last updated on May 28, 2008.   Information provided by Allergan

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Descriptive Information Fields
Brief Title  Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
Official Title 
Brief Summary

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

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Dry eye symptoms as measured by OSDI© [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  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 ]
Condition  Dry Eye Syndrome
Intervention  Drug: Carboxymethylcellulose and Glycerin based artificial tear
Drug: Carboxymethylcellulose
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  316
Start Date  October 2007
Completion Date January 2008
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00514852
Organization ID AG9818-002
Secondary IDs ††
Study Sponsor  Allergan
Collaborators ††
Investigators 
Study Director:     Medical Director     Allergan    
Information Provided By Allergan
Verification Date May 2008
First Received Date  August 8, 2007
Last Updated Date May 28, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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