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Phase II Study of AL-2178 (FID 109980) in the Treatment of Dry Eye

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00471419
First Posted: May 9, 2007
Last Update Posted: June 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alcon Research
  Purpose
The purpose of this study is to see if Rimexolone (FID 109980) is a safe and effective treatment of dry eye.

Condition Intervention Phase
Dry Eye Drug: Rimexolone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase II Study of AL-2178 (FID 109980) in the Treatment of Dry Eye

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corneal staining; dry eye sympton [ Time Frame: Immediate ]

Secondary Outcome Measures:
  • Corneal staining; dry eye sympton [ Time Frame: Prolonged ]

Estimated Enrollment: 750
Study Start Date: July 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • documented dry eye history
  • ocular symptoms
  • tear use
  • dry eye ocular signs

Exclusion Criteria:

  • Under 18
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471419


Locations
United States, Ohio
Cleveland
Cleveland, Ohio, United States, 44115
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Michael Brubaker, PhD Alcon Research
  More Information

ClinicalTrials.gov Identifier: NCT00471419     History of Changes
Other Study ID Numbers: C-05-31
First Submitted: May 7, 2007
First Posted: May 9, 2007
Last Update Posted: June 5, 2012
Last Verified: March 2008

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Rimexolone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs