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

• Sponsor: Santen Oy (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00596791
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Duration (Months): 7
• Patients Per Site Per Month: 21.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension; Open-Angle Glaucoma	Drug: tafluprost	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 arm Open-lable study with one arm.	Drug: tafluprost; prostaglandine analoque

Outcome Measures

Primary Outcome Measures

1. Change from screening in ocular symptoms and signs [at week 6 and 12]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Finn-Medi Research Oy	Tampere		Finland	33520

Sponsors and Collaborators

• Santen Oy

Investigators

• Principal Investigator: Hannu Uusitalo, Professor, Finn-Medi Research, Finland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00596791
• Other Study ID Numbers: Santen-77552; EudraCT number 2007-004872-37
• First Posted: Jan 17, 2008
• Last Update Posted: Jan 12, 2009
• Last Verified: Jan 1, 2009

• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension

Study Results

No Results Posted as of Jan 12, 2009