Status:
COMPLETED
Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time
Lead Sponsor:
Alcon Research
Conditions:
Dry Eye Disease
Eligibility:
All Genders
20-64 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to observe lacrimal fluid condition (tear film break-up time) chronologically after a single dose of AL-43546 ophthalmic products（0.15%, 0.25% and vehicle）and 0.1% sodium h...
Eligibility Criteria
Inclusion
- Subjects with NIBUT of either eye is 8 seconds or less and other eye is 10 seconds or less at screening test and NIBUT of either eye before instillation in Period I is 10 seconds or less.
Exclusion
- Diagnosis of severe Sjogren's syndrome (history of the use of punctal plug one time or more, etc.) in either eye.
- Subjects who will use ophthalmic solutions (excluding the specified artificial tear) or ophthalmic ointment in either eye during the study period.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00760045
Start Date
August 1 2008
Last Update
January 6 2010
Active Locations (1)
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1
Osaka Pharmacology Clinical Research Hospital
Osaka, Osaka, Japan, 532-0003