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
  Purpose

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.


Condition Intervention
Ocular Physiology
Intraocular Pressure
Regional Blood Flow
Drug: Latanoprost 0.005%, Xalatan®
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Effects of Latanoprost on Choroidal Blood Flow Regulation in Human Subjects

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Choroidal pressure-flow relationship [ Time Frame: in total 4 hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2005
Study Completion Date: January 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Latanoprost 0.005%, Xalatan®
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
Placebo Comparator: 2
Vehicle to latanoprost (eyedrops containing the same stabilizers as latanoprost, but no active drug)
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

  Eligibility

Ages Eligible for Study:   19 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712400

Locations
Austria
Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gabriele Fuchsjäger-Mayrl; MD, Department of Clinical Pharmacology
ClinicalTrials.gov Identifier: NCT00712400     History of Changes
Other Study ID Numbers: OPHT-070703
Study First Received: July 8, 2008
Last Updated: January 24, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Latanoprost
Choroidal Blood Flow
Intraocular Pressure

Additional relevant MeSH terms:
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014