drugset / Trial / NCT01292460

Tafluprost-Timolol Preservative-free Fixed Dose Combination (FDC) Superiority Study Against Monotherapies

NCT01292460

Phase 3 Completed 600 enrolled Santen Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the efficacy and safety of the preservative-free fixed tafluprost-timolol combination to those of tafluprost and timolol alone. This study will enroll patients who have ocular hypertension or glaucoma and who are using timolol or prostaglandin. The study medication period is 6 months, but the primary evaluation of efficacy is done at 3 months.

Timeline

Start
2011-02
Primary completion
2012-09
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject FDC Unknown 0.0015 % Topical
Subject FDC Unknown 0.5 % Topical
Subject Tafluprost Other / unclassified 0.0015 % Topical
Subject Timolol Other / unclassified 0.5 % Topical