Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops

Phase 3

Completed

• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Interventions: Drug: tafluprost

• Registration Number: NCT00596791
• Lead Sponsor: Santen Oy

Brief Summary

The purpose of this study is to investigate if changes in ocular signs and symptoms occur in patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005% (Xalatan) to preservative free Tafluprost eye drops.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-17
• Primary Completion: 2008-07
• Study Completion: 2008-08
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-09
• Last Update Posted: 2009-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients with a diagnosis of ocular hypertension or open angle glaucoma for which the patient has been using latanoprost 0.005% as his/her prior medication. - Evaluable patients must have ocular surface related symptoms and/or signs with their prior medication.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1 arm	tafluprost	Open-lable study with one arm.

Primary Outcome Measures

Name	Time	Method
Change from screening in ocular symptoms and signs	at week 6 and 12

Secondary Outcome Measures

Name	Time	Method
Safety and Quality of life parameters.	From Screening (visit 1) to visits at week 2, 6 and 12.

Trial Locations

Locations (1)

Finn-Medi Research Oy; 🇫🇮 Tampere, Finland