Effects of common topical glaucoma therapy on optic nerve head blood flow autoregulation during increased arterial blood pressure and artificially elevated intraocular pressure in healthy humans
- Conditions
- only healthy volunteers are included
- Registration Number
- EUCTR2005-005895-34-AT
- Lead Sponsor
- Department of Clinical Pharmacology, Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 54
54 healthy male subjects
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, ametropy < 1 Dpt.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
-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
- Blood donation during the previous 3 weeks
- Presence of intraocular pathology: ocular hypertension, glaucoma, retinal vasculopathy or other retinal diseases
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the influence of common topical glaucoma therapy on ONH blood flow regulation during changes in IOP and systemic arterial blood pressure.;Secondary Objective: none;Primary end point(s): as scheduled by protocol
- Secondary Outcome Measures
Name Time Method