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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00471419
First received: May 7, 2007
Last updated: June 3, 2012
Last verified: March 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase II Study of AL-2178 (FID 109980) in the Treatment of Dry Eye

Resource links provided by NLM:

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00471419     History of Changes
Other Study ID Numbers: C-05-31
Study First Received: May 7, 2007
Last Updated: June 3, 2012
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013