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.

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure; Ocular Physiology; Regional Blood Flow
• Intervention / Treatment: Drug: Latanoprost 0.005%, Xalatan®; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Choroidal pressure-flow relationship	in total 4 hours

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Publications and helpful links

General Publications

• Boltz A, Schmidl D, Weigert G, Lasta M, Pemp B, Resch H, Garhofer G, Fuchsjager-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.

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: July 8, 2008
• First Submitted That Met QC Criteria: July 8, 2008
• First Posted (ESTIMATE): July 10, 2008

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2018
• Last Update Submitted That Met QC Criteria: June 7, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Intraocular Pressure; Latanoprost; Choroidal Blood Flow
• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: OPHT-070703