Who is sponsoring NCT01306461?

NCT01306461 is sponsored by Santen Oy.

What condition does NCT01306461 study?

NCT01306461 studies Ocular Hypertension, Open-angle Glaucoma.

What drugs are being tested in NCT01306461?

Interventions: Timolol and Tafluprost, Fixed Dose Combination of tafluprost and timolol.

What is the status of NCT01306461?

NCT01306461 is currently COMPLETED.

Last reviewed 2012-06-07 · How we verify

A Phase III, Randomized, Double-masked 6-month Trial to Compare the Efficacy and Safety of the Preservative-free Fixed-dose Combination of Tafluprost and Timolol Eye Drops to Those of Tafluprost and Timolol Eye Drops Given Concomitantly in Patients With Open Angle Glaucoma or Ocular Hypertension

NCT01306461 Phase 3 COMPLETED

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

Details

Lead sponsor	Santen Oy
Phase	Phase 3
Status	COMPLETED
Enrolment	401
Start date	2011-03
Completion	2012-05

Conditions

Ocular Hypertension
Open-angle Glaucoma

Interventions

Timolol and Tafluprost
Fixed Dose Combination of tafluprost and timolol

Primary outcomes

Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months — 6 months

Countries

Hungary