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...
Date First Received: January 8, 2008
Last Updated: February 14, 2008
Verified by: Santen Oy, February 2008
Clinical Trial Phase: Phase 3 | Start Date: January 2008
Overall Status: Recruiting
Estimated Enrollment: 150
Brief Summary
Official Title: “Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops”
Condition Keyword(s):
Intervention(s):
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: Treatment, Open Label, Single Group Assignment
Study Primary Completion Date: June 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
- Time Frame: at week 6 and 12
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
- Time Frame: From Screening (visit 1) to visits at week 2, 6 and 12.
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 Sponsor Information
Lead Sponsor: Santen Oy
Overall Clinical Trial Officials and Contacts
Hannu Uusitalo, Professor Principal Investigator Finn-Medi Research, Finland
Overall Contact: Anneli Skinnari, Project Manager +358405811988 anneli.skinnari@santen.fi
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00596791
Study ID Number: Santen-77552
ClinicalTrials.gov Identifier: NCT00596791
Health Authority: Finland: National Agency for Medicines
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