E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with primary open angle glaucoma in comparision to a healthy control group. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To test the hypothesis that the endothelin antagonist bosentan increases ocular blood flow in patients with primary open angle glaucoma. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
as stated in the protocol |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |