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

This study has been completed.
Sponsor:
Information provided by:
Santen Oy
ClinicalTrials.gov Identifier:
NCT00596791
First received: January 8, 2008
Last updated: January 9, 2009
Last verified: January 2009
  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: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014