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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00918346 |
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Date of registration:
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09/06/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation
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Scientific title:
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Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation in Patients With Open-angle Glaucoma or Ocular Hypertension |
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Date of first enrolment:
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September 2005 |
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Target sample size:
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43 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00918346 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Finland
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Germany
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Contacts
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Name:
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Juhani Airaksinen, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of Oulu |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Open-Angle Glaucoma
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Ocular Hypertension
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Intervention(s)
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Drug: Tafluprost 0.0015%
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Primary Outcome(s)
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Intraocular Pressures (IOPs) at Baseline
[Time Frame: Baseline]
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Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
[Time Frame: Baseline - Week 4]
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Intraocular Pressures (IOPs) at Week 4
[Time Frame: Week 4]
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Intraocular Pressures (IOPs) at Week 1
[Time Frame: Week 1]
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Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
[Time Frame: Baseline - Week 4]
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Secondary Outcome(s)
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Overall and Time-wise Comparisons of IOP at Week 1
[Time Frame: Baseline - Week 1]
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Change From Baseline in Time-wise IOPs at Week 4
[Time Frame: Baseline - Week 4]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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