patients with primary open angle glaucoma in comparision to a healthy control group.
Conditions
Interventions
Trade Name: Tracleer@ 125 mg Filmtabletten
Pharmaceutical Form: Tablet
Sponsors
Department of Clinical Pharmacology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Austria
Outcome results
None listed