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

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ClinicalTrials.gov Identifier: NCT00471419
Recruitment Status : Completed
First Posted : May 9, 2007
Last Update Posted : June 5, 2012
Sponsor:
Information provided by:
Alcon Research

Brief Summary:
The purpose of this study is to see if Rimexolone (FID 109980) is a safe and effective treatment of dry eye.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Rimexolone Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
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
Study Start Date : July 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

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




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

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


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

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

ClinicalTrials.gov Identifier: NCT00471419     History of Changes
Other Study ID Numbers: C-05-31
First Posted: May 9, 2007    Key Record Dates
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