Status:
COMPLETED
Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
Lead Sponsor:
Santen Pharmaceutical Co., Ltd.
Conditions:
Dry Eye
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1...
Eligibility Criteria
Inclusion
- Those who show:
- Keratoconjunctival disorder confirmed with vital dye staining
- Abnormal Schirmer score results
Exclusion
- Eye disease that needs therapy other than that for dry eye
- Those who need to wear contact lenses during the clinical study
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT01240382
Last Update
August 13 2014
Active Locations (1)
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1
Santen study sites
Osaka, Osaka, Japan