Phase II Study of AL-2178 (FID 109980) in the Treatment of Dry Eye
Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00471419
Collaborator
(none)
750
1
13
57.6
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Anticipated 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
:
Jul 1, 2006
Actual Primary Completion Date
:
Aug 1, 2007
Actual Study Completion Date
:
Aug 1, 2007
Outcome Measures
Primary Outcome Measures
- Corneal staining; dry eye sympton [Immediate]
Secondary Outcome Measures
- Corneal staining; dry eye sympton [Prolonged]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland | Cleveland | Ohio | United States | 44115 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Michael Brubaker, PhD, Alcon Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00471419
Other Study ID Numbers:
- C-05-31
First Posted:
May 9, 2007
Last Update Posted:
Jun 5, 2012
Last Verified:
Mar 1, 2008