Effects of Topical Clonidine vs. Brimonidine on Choroidal Blood Flow and Intraocular Pressure During Isometric Exercise

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT00312416
Collaborator
(none)
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Study Details

Study Description

Brief Summary

Brimonidine tartrate is an alpha-2 agonist ocular hypotensive drug that exerts its effect by causing both a decrease in aqueous production and an increase in uveoscleral outflow. It has been proven to reduce increased intraocular pressure in glaucoma and ocular hypertension. As an alpha 2 agonist Brimonidine belongs to the same class of drugs as Clonidine; however, its molecular structure is sufficiently different to make it more selective for the alpha 2 receptor than Clonidine. Unlike Clonidine, Brimonidine does not appear to have an effect on the central nervous system and therefore does not cause sedation or systemic hypotension.

In addition to their known effect of lowering intraocular pressure, alpha 2 adrenoceptor agonists are neuroprotective. It has, however, been shown that Brimonidine is a very potent vasoconstrictor in the ciliary body thus reducing aqueous humor production. Little is, however, known about potential vasoconstrictor effects of Brimonidine in the posterior pole of the eye. This is of clinical importance, because optic nerve head ischemia appears to contribute to glaucoma pathophysiology.

This study is performed to investigate the effects of topical Clonidine vs. topical Brimonidine on choroidal blood flow and intraocular pressure during isometric exercise.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Effects of Topical Clonidine vs. Brimonidine on Choroidal Blood Flow and Intraocular Pressure During Isometric Exercise
Study Start Date :
Feb 1, 2004
Study Completion Date :
Dec 1, 2004

Outcome Measures

Primary Outcome Measures

  1. Choroidal pressure-flow relationship []

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 35 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Men aged between 19 and 35 years, nonsmokers

  • Body mass index between 15th and 85th percentile (Must A 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, ametropy < 3 Dpt.

  • Intraocular pressure between 10 and 18 mmHg.

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 of hypersensitivity to the trial drug or to drugs with a similar chemical structure

  • 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

  • History or family history of epilepsy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Clinical Pharmacology Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Gabriele Fuchsjäger-Mayrl, M.D., Deapartment of Clinical Pharmacology, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00312416
Other Study ID Numbers:
  • OPHT-121203B
First Posted:
Apr 10, 2006
Last Update Posted:
Feb 12, 2007
Last Verified:
Feb 1, 2007
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 12, 2007