drugset / Trial / NCT01306461

Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations

NCT01306461

Phase 3 Completed 401 enrolled Santen Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost and timolol (FDC) to concomitant administration of tafluprost and timolol. This study will enroll patients who have ocular hypertension or glaucoma. The study schedule includes seven visits to the study site and three stages: * washout of 5 days to 4 weeks depending on current glaucoma medication (if any) * 6-month study treatment period * 1-3 weeks post-study period

Timeline

Start
2011-03
Primary completion
2012-04
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tafluprost Other / unclassified Other
Subject Timolol Other / unclassified Other