Back to resultsPhase II Study of AL-2178 (FID 109980) in the Treatment of Dry Eye
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rimexolone
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- documented dry eye history
- ocular symptoms
- tear use
- dry eye ocular signs
Exclusion Criteria:
- Under 18
Sites / Locations
- Cleveland
Outcomes
Primary Outcome Measures
Corneal staining; dry eye sympton
Secondary Outcome Measures
Corneal staining; dry eye sympton
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00471419
Brief Title
Phase II Study of AL-2178 (FID 109980) in the Treatment of Dry Eye
Official Title
Phase II Study of AL-2178 (FID 109980) in the Treatment of Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to see if Rimexolone (FID 109980) is a safe and effective treatment of dry eye.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rimexolone
Primary Outcome Measure Information:
Title
Corneal staining; dry eye sympton
Time Frame
Immediate
Secondary Outcome Measure Information:
Title
Corneal staining; dry eye sympton
Time Frame
Prolonged
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
documented dry eye history
ocular symptoms
tear use
dry eye ocular signs
Exclusion Criteria:
Under 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Brubaker, PhD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of AL-2178 (FID 109980) in the Treatment of Dry Eye
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