Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops
This study has been completed.
Sponsor:
Santen Oy
Information provided by:
Santen Oy
ClinicalTrials.gov Identifier:
NCT00596791
First received: January 8, 2008
Last updated: January 9, 2009
Last verified: January 2009
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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:
Genetics Home Reference related topics:
early-onset glaucoma
Drug Information available for:
Tafluprost
U.S. FDA Resources
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
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:
|
Glaucoma Ocular Hypertension Signs and Symptoms Eye Diseases |
ClinicalTrials.gov processed this record on February 27, 2015