Effects of non-specific Endothelin-A receptor blockade on ocular blood flow in patients with glaucoma
- Conditions
- patients with primary open angle glaucoma in comparision to a healthy control group.
- Registration Number
- EUCTR2006-003140-27-AT
- Lead Sponsor
- Department of Clinical Pharmacology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 28
- Men and women aged over 18 years
- Normal findings in the medical history and physical examination unless the investigator considers an
abnormality to be clinically irrelevant
- Inclusion criteria for patients is primary open angle glaucoma defined as pathological optic disc appearance
and characteristic visual field loss
- Men and women will be included in equal parts
- Ametropia of less than 6 diopters and anisometropia of less than 2 diopters
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria (glaucoma patients)
- Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Smoking
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- 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
- Ametropy > 6 dpt
- Systemic treatment with, oral antikoagulation, Glibenclamid or vasoactive drugs
- History of IOP > 30 (untreated)
- Presence of intraocular pathology other than glaucoma
- Advanced visual field defect defined as MD >-10
- Presence of PEX (pseudoexfoliation) glaucoma and pigment glaucoma
- Ophthalmolgical surgery (including argon laser trabeculoplasty (ALT), trabeculectomy, deep sclerectomy)
within the last 6 months before the study
- Pregnancy
- Diabetes mellitus
Exclusion criteria (healthy controls)
- Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Smoking
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- 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
- Ametropy > 6 dpt
- Systemic treatment with oral anticoagulation, Glibenclamid or vasoactive drugs
- Pregnancy
- Diabetes mellitus
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To test the hypothesis that the endothelin antagonist bosentan increases ocular blood flow in patients with primary open angle glaucoma.;Secondary Objective: none;Primary end point(s): as stated in the protocol
- Secondary Outcome Measures
Name Time Method