drugset / Trial / NCT01342081

DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%

NCT01342081

Phase 3 Completed 489 enrolled Santen Pharmaceutical Co., Ltd.
Parallel-groupTriple-blindTreatment

Summary

DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and Timolol ophthalmic solution 0.5% used concomitantly, in IOP(intraocular pressure) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.

Timeline

Start
2011-05
Primary completion
2012-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject DE-111 Unknown Other
Comparator Tafluprost Other / unclassified 0.0015 % Other
Comparator Timolol Other / unclassified 0.5 % Other