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

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.
 
ClinicalTrials.gov Identifier: NCT00596791
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : January 12, 2009
Sponsor:
Information provided by:
Santen Oy

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Tafluprost

Arms and Interventions
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Arm Intervention/treatment
1 arm
Open-lable study with one arm.
 Drug: tafluprost
prostaglandine analoque


Outcome Measures
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Primary Outcome Measures :
  1. Change from screening in ocular symptoms and signs [ Time Frame: at week 6 and 12 ]

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Finland
Finn-Medi Research Oy
Tampere, Finland, 33520
Sponsors and Collaborators
Santen Oy
Investigators
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Principal Investigator: Hannu Uusitalo, Professor Finn-Medi Research, Finland
More Information
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Responsible Party: Auli Ropo, Study Director, Santen Oy
ClinicalTrials.gov Identifier: NCT00596791    
Other Study ID Numbers: Santen-77552
EudraCT number 2007-004872-37
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: January 12, 2009
Last Verified: January 2009
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases