Status:
COMPLETED
Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation
Lead Sponsor:
Santen Oy
Conditions:
Open-Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to investigate the pharmacodynamics (as expressed in intraocular pressure \[IOP\]) of two formulations of tafluprost 0.0015% eyedrops (preserved and unpreserved) in pati...
Eligibility Criteria
Inclusion
- Age 18 years or more
- A diagnosis of open angle glaucoma or ocular hypertension
- Prior use of prostaglandin(s)
- Intra ocular pressure of 22-34 mmHg in at least one eye
Exclusion
- Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
- Previous participation in any clinical trial in which tafluprost was an investigational drug or use of contact lenses at screening or during the study
- Presence of any abnormality or significant illness that could be expected to interfere with the study
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00918346
Start Date
September 1 2005
End Date
April 1 2006
Last Update
December 28 2010
Active Locations (3)
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1
Oulu University Hospital
Oulu, Finland, 90029
2
Ulrich Richter's surgery
Regensburg, Germany, 93059
3
Praxis Dr. Hamacher
Starnberg, Germany, 82319