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Effects of Latanoprost on Choroidal Blood Flow Regulation in Human Subjects

This study is currently recruiting participants.
Study NCT00712400.   Last updated on July 8, 2008.   Information provided by Medical University of Vienna

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Descriptive Information Fields
Brief Title  Effects of Latanoprost on Choroidal Blood Flow Regulation in Human Subjects
Official Title  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.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Diagnostic, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Choroidal pressure-flow relationship [ Time Frame: in total 4 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Ocular Physiology
Intraocular Pressure
Regional Blood Flow
Intervention  Drug: Latanoprost 0.005%, Xalatan®
Drug: Placebo
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  32
Start Date  June 2005
Completion Date February 2009
Eligibility Criteria 

Inclusion Criteria:

  • Men aged between 19 and 35 years, nonsmokers
  • Body mass index between 15th and 85th percentile (Must et al. 1991)
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropia < 3 dpt.

Exclusion Criteria:

  • Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Treatment in the previous 3 weeks with any drug
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
  • Blood donation during the previous 3 weeks
  • Ametropia >= 3 dpt
  • Iris bicolor
Gender Male
Ages 19 Years to 35 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Gerhard Garhofer, MD     0043 1 40400 ext 2981     klin-pharmakologie@meduniwien.ac.at    
Location Countries  Austria
Administrative Information Fields
NCT ID  NCT00712400
Organization ID OPHT-070703
Secondary IDs ††
Study Sponsor  Medical University of Vienna
Collaborators ††
Investigators 
Information Provided By Medical University of Vienna
Verification Date July 2008
First Received Date  July 8, 2008
Last Updated Date July 8, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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