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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00596791
First Posted: January 17, 2008
Last Update Posted: January 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Santen Oy
  Purpose
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: 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

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 ]

Secondary Outcome Measures:
  • Safety and Quality of life parameters. [ Time Frame: From Screening (visit 1) to visits at week 2, 6 and 12. ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596791


Locations
Finland
Finn-Medi Research Oy
Tampere, Finland, 33520
Sponsors and Collaborators
Santen Oy
Investigators
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
First Submitted: January 8, 2008
First Posted: January 17, 2008
Last Update Posted: January 12, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Signs and Symptoms
Eye Diseases
Ophthalmic Solutions
Latanoprost
Pharmaceutical Solutions
Antihypertensive Agents