Status:
UNKNOWN
Comparison of Efficacy, Safety and Anti-Inflammatory Effect Between Topical 0.05%Cyclosporine A Emulsion and REFRESH® in Patients With Moderate to Severe Dry Eyes
Lead Sponsor:
Chulalongkorn University
Collaborating Sponsors:
Allergan
Conditions:
Dry Eye
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
To compare the efficacy, safety and tolerability of 0.05% topical cyclosporin eye drop to Refresh in moderate to severe dry eye patients. Null hypothesis is: there is no difference between these two g...
Detailed Description
Inclusion criteria: 1. Participants are moderate to severe dry eye patients aged more than 18 years of age 2. Oxford staining scores of more than five. 3. OSDI scores of more than 0.1 Outcome measur...
Eligibility Criteria
Inclusion
- moderate to severe dry eye
Exclusion
- lid anomaly, previous CsA use
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00704275
Start Date
June 1 2007
End Date
October 1 2008
Last Update
June 24 2008
Active Locations (2)
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1
OPD Chulalongkorn University Hospital
Bangkok, Thailand, 10330
2
OPD Chulalongkorn University Hospital
Bangkok, Thailand