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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 8, 2008 | ||||
| Last Updated Date | July 8, 2008 | ||||
| Start Date ICMJE | June 2005 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Choroidal pressure-flow relationship [ Time Frame: in total 4 hours ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Latanoprost on Choroidal Blood Flow Regulation in Human Subjects | ||||
| Official Title ICMJE | Effects of Latanoprost on Choroidal Blood Flow Regulation in Human Subjects | ||||
| Brief Summary | Latanoprost is a synthetic prodrug of 17-phenyl-substituted prostaglandin F2α analog. Used at a dose of one drop per day, it has been reported to produce a 30 to 35% reduction in intraocular pressure. Its mechanism of activation involves augmentation of the eye's natural uveoscleral outflow capacity . There is evidence that ocular blood flow plays a role in the clinical course of glaucoma. Glaucoma medication that lowers IOP simultaneously increases ocular blood perfusion pressure, which in turn may increase ocular blood flow. This could well contribute to the partially contradicting results concerning ocular hemodynamic effects of latanoprost. In vitro studies indicate that latanoprost has no effect on ocular vascular tone in therapeutical doses. By contrast, it has been reported in several studies that latanoprost 0.005% increases pulsatile ocular blood flow in patients with primary open angle glaucoma and normal tension glaucoma. This increase in pulsatile ocular blood flow mainly reflects an increase in the choroidal circulation. Little is known about the potential effect of latanoprost on choroidal blood flow regulation in humans. The present study therefore tries to elucidate whether treatment with latanoprost may alter choroidal blood flow regulation during artificial changes in ocular perfusion pressure. In addition, the present study aims to clarify whether the change in choroidal blood flow after latanoprost administration are due to direct vasoactive effects or due to the increase in ocular perfusion pressure. The second alternative may have important implications on our understanding of glaucoma treatment, because reduction of IOP may then per se result in normalization of ocular blood flow regulation. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 32 | ||||
| Estimated Completion Date | February 2009 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 19 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Austria | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00712400 | ||||
| Responsible Party | Gabriele Fuchsjäger-Mayrl; MD, Department of Clinical Pharmacology | ||||
| Study ID Numbers ICMJE | OPHT-070703 | ||||
| Study Sponsor ICMJE | Medical University of Vienna | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE | |||||
| Information Provided By | Medical University of Vienna | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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