Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
Alcon Research Identifier:
First received: May 7, 2007
Last updated: June 3, 2012
Last verified: March 2008
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-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:

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)

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Under 18
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00471419

United States, Ohio
Cleveland, Ohio, United States, 44115
Sponsors and Collaborators
Alcon Research
Study Director: Michael Brubaker, PhD Alcon Research
  More Information Identifier: NCT00471419     History of Changes
Other Study ID Numbers: C-05-31
Study First Received: May 7, 2007
Last Updated: June 3, 2012

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 22, 2017