NCT01292460

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

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 Given Individually in Patients With Open Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• 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 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.

Conditions

• Ocular Hypertension
• Open-angle Glaucoma

Interventions

Type	Name	Description
DRUG	Timolol/ FDC/ Placebo/ Tafluprost	Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00). Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-02-09
• Last updated: 2013-03-13

Locations

2 sites across 1 country: Finland