NCT Number: NCT00279253
Effects of Intravenous Clonidine on Ocular Blood Flow and Intraocular Pressure
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.
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Notify MeKey information
Conditions
Age range
19 year–35 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 4
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
ocular blood flow
Sponsors and collaborators
Lead sponsor
Medical University of Vienna
Other
Registry information
Important dates
- Study start
- 2004
- Study completion
- 2005
- First posted
- Jan 19, 2006
- Registry last updated
- Jan 19, 2006
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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