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

Verified by: Santen Oy, January 2009
First Received: January 8, 2008 | Last Updated: January 9, 2009 | Phase: Phase 3 | Start Date: January 2008
Overall Status: Completed | Estimated Enrollment: 150
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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...

Brief Summary

Official Title: “Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops”

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.

  • Study Type: Interventional
  • Study Design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

  • Drug: tafluprost
    • prostaglandine analoque

Arms, Groups and Cohorts in this Clinical Trial

  • Other: 1 arm
    • Open-lable study with one arm.

Outcome Measures for this Clinical Trial

Primary Measures

  • Change from screening in ocular symptoms and signs
    • Time Frame: at week 6 and 12
      Safety Issue?: No

Secondary Measures

  • Safety and Quality of life parameters.
    • Time Frame: From Screening (visit 1) to visits at week 2, 6 and 12.
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Santen Oy Industry

Overall Clinical Trial Officials and Contacts

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

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00596791

Study ID Number: Santen-77552

ClinicalTrials.gov Identifier: NCT00596791

Health Authority: Finland: Finnish Medicines Agency

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00596791