NCT01306461

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: Santen Oy · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ocular Hypertension
• Open-angle Glaucoma

Interventions

Type	Name	Description
DRUG	Timolol and Tafluprost	Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily Treatment period 6 months
DRUG	Fixed Dose Combination of tafluprost and timolol	Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops administered once daily. For masking purposes also: vehicle for timolol administered twice daily Treatment period 6 months

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-04-01
• Completion: 2012-05-01
• First posted: 2011-03-01
• Last updated: 2012-06-08

Locations

1 site across 1 country: Hungary