Back to resultsOcular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops
Primary Purpose
Ocular Hypertension, Open-Angle Glaucoma
Status
Completed
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
tafluprost
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension
Eligibility 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.
Sites / Locations
- Finn-Medi Research Oy
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1 arm
Arm Description
Open-lable study with one arm.
Outcomes
Primary Outcome Measures
Change from screening in ocular symptoms and signs
Secondary Outcome Measures
Safety and Quality of life parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00596791
Brief Title
Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops
Official Title
Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Santen Oy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Open-Angle Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 arm
Arm Type
Other
Arm Description
Open-lable study with one arm.
Intervention Type
Drug
Intervention Name(s)
tafluprost
Intervention Description
prostaglandine analoque
Primary Outcome Measure Information:
Title
Change from screening in ocular symptoms and signs
Time Frame
at week 6 and 12
Secondary Outcome Measure Information:
Title
Safety and Quality of life parameters.
Time Frame
From Screening (visit 1) to visits at week 2, 6 and 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannu Uusitalo, Professor
Organizational Affiliation
Finn-Medi Research, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Finn-Medi Research Oy
City
Tampere
ZIP/Postal Code
33520
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops
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