Effects of Latanoprost on Choroidal Blood Flow Regulation in Human Subjects

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00712400
First received: July 8, 2008
Last updated: January 24, 2012
Last verified: January 2012

July 8, 2008
January 24, 2012
June 2005
September 2009   (final data collection date for primary outcome measure)
Choroidal pressure-flow relationship [ Time Frame: in total 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00712400 on ClinicalTrials.gov Archive Site
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Effects of Latanoprost on Choroidal Blood Flow Regulation in Human Subjects
Effects of Latanoprost on Choroidal Blood Flow Regulation in Human Subjects

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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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
  • Ocular Physiology
  • Intraocular Pressure
  • Regional Blood Flow
  • Drug: Latanoprost 0.005%, Xalatan®
    Substance: Latanoprost 0.005%, Xalatan® (Pharmacia Austria Ges.m.b.H. Oberlaaer Straße 251, 1101 Vienna) Dosage form: topical application in one eye Dosage: 1 drop in the evening for 14 days
  • Drug: Placebo
    Substance: Vehicle to latanoprost (eyedrops containing the same stabilizers as latanoprost, but no active drug) Dosage form: topical application in one eye Dosage: 1 drop in the evening for 14 days
  • Active Comparator: 1
    Latanoprost 0.005%, Xalatan®
    Intervention: Drug: Latanoprost 0.005%, Xalatan®
  • Placebo Comparator: 2
    Vehicle to latanoprost (eyedrops containing the same stabilizers as latanoprost, but no active drug)
    Intervention: Drug: Placebo
Boltz A, Schmidl D, Weigert G, Lasta M, Pemp B, Resch H, Garhöfer G, Fuchsjäger-Mayrl G, Schmetterer L. Effect of latanoprost on choroidal blood flow regulation in healthy subjects. Invest Ophthalmol Vis Sci. 2011 Jun 22;52(7):4410-5. doi: 10.1167/iovs.11-7263.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
January 2010
September 2009   (final data collection date for primary outcome measure)

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
Male
19 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00712400
OPHT-070703
Yes
Gabriele Fuchsjäger-Mayrl; MD, Department of Clinical Pharmacology
Medical University of Vienna
Not Provided
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Medical University of Vienna
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP