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| Sponsor: | Medical University of Vienna |
|---|---|
| Information provided by: | Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00279253 |
Purpose
Background Clonidine, a derivate of Imidazol, is an antihypertensive drug. It acts by stimulating adrenergic receptors on nerves in the brain and Imidazol-receptors. As a result, clonidine slows the heart rate and reduces blood pressure. Clonidine was approved by the FDA in 1974 and is registered in Austria with the brand name “Catapresan”.
Alpha2 adrenergic agonists are nowadays used topically as eye drops in glaucoma treatment. In addition to their known effect of lowering intraocular pressure, alpha2 adrenoceptor agonists are neuroprotective. Brimonidine, which is the most commonly used topical alpha-2 agonist, is currently on the market for treatment of glaucoma and is effective in reducing intraocular pressure. 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. Direct investigation of the ocular hemodynamic effects of brimonidine is, however, difficult, because lowering intraocular pressure with brimonidine may confound the results due to the concomitant change in ocular perfusion pressure.
The aim of the present study is to assess the effect of intravenous clonidine as model drug of alpha agonists on ocular blood flow and IOP in healthy humans.
Study objectives:
To investigate effects of clonidine on ocular blood flow and intraocular pressure.
| Condition | Intervention | Phase |
|---|---|---|
|
Physiology |
Drug: clonidine (drug) intravenously |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Eligibility| Ages Eligible for Study: | 19 Years to 35 Years |
| Genders 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
Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
Normal ophthalmic findings, ametropy < 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 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 More Information
| Study ID Numbers: | OPHT-141003 |
| Study First Received: | January 18, 2006 |
| Last Updated: | January 18, 2006 |
| ClinicalTrials.gov Identifier: | NCT00279253 History of Changes |
| Health Authority: | Austria: Bundesministerium für Gesundheit und Frauen |
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clonidine glaucoma |
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Sympatholytics Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Clonidine Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents |
Adrenergic Agonists Pharmacologic Actions Autonomic Agents Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents |
