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CompletedNCT00312416Updated Feb 12, 2007

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

A Phase 4 interventional study of Clonidin and Brimonidine in Ocular Physiology and Regional Blood Flow, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to male participants aged 19 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-02-12.

Sponsored by Medical University of Vienna · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
19 Years to 35 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Ocular Physiology
  • Regional Blood Flow

Keywords

  • Choroidal blood flow
  • Clonidin
  • Brimonidin
03

In context

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 35 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
18 participants

Interventions

  • DrugClonidin
  • DrugBrimonidine
06

What researchers measure

Primary outcomes

  1. Choroidal pressure-flow relationship

07

Study locations

1 site
  • Department of Clinical Pharmacology
    Vienna, 1090, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00312416
Lead sponsor
Medical University of Vienna
First posted
Apr 10, 2006
Start date
Feb 2004
Completion
Dec 2004
Last update
Feb 12, 2007

Study contacts

Gabriele Fuchsjäger-Mayrl, M.D.
principal investigator · Deapartment of Clinical Pharmacology, Medical University of Vienna
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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