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

This study has been completed.
Information provided by:
Santen Oy
ClinicalTrials.gov Identifier:
First received: January 8, 2008
Last updated: January 9, 2009
Last verified: January 2009
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 Intervention Phase
Ocular Hypertension
Open-Angle Glaucoma
Drug: tafluprost
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Santen Oy:

Primary Outcome Measures:
  • Change from screening in ocular symptoms and signs [ Time Frame: at week 6 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Quality of life parameters. [ Time Frame: From Screening (visit 1) to visits at week 2, 6 and 12. ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 arm
Open-lable study with one arm.
Drug: tafluprost
prostaglandine analoque


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00596791

Finn-Medi Research Oy
Tampere, Finland, 33520
Sponsors and Collaborators
Santen Oy
Principal Investigator: Hannu Uusitalo, Professor Finn-Medi Research, Finland
  More Information

Responsible Party: Auli Ropo, Study Director, Santen Oy
ClinicalTrials.gov Identifier: NCT00596791     History of Changes
Other Study ID Numbers: Santen-77552  EudraCT number 2007-004872-37 
Study First Received: January 8, 2008
Last Updated: January 9, 2009
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Signs and Symptoms
Eye Diseases
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 04, 2016