The study will be carried out in patients with primary open angle glaucoma and healthy subjects MedDRA version: 20.0 Level: LLT Classification code 10036719 Term: Primary open angle glaucoma System Organ Class: 100000004853
Conditions
Interventions
Product Name: Dronabinol
Product Code: A04AD10
Pharmaceutical Form: Capsule
INN or Proposed INN: DRONABINOL
CAS Number: 1972-08-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
Medical University of Vienna, Department of Clinical Pharmacology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for patients with primary open angle glaucoma: • Diagnosis of manifest open angle glaucoma as defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and/or untreated IOP = 21 mmHg on at least three measurements in the medical history. • Mean deviation in the visual field test =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Exclusion criteria for patients with primary open angle glaucoma: • Exfoliation glaucoma • Pigmentary glaucoma • Secondary glaucoma • History of acute angle closure • Intraocular surgery within the last 6 months • Filtration surgery for glaucoma at any time • Laser procedure for glaucoma within the last 12 months • Visual field not performed or not available within 6 months • Ocular inflammation or infection within the last 3 months • Regular use of medication that potentially could interact with THC, abuse of alcoholic beverages or drugs • History of drug or alcohol abuse • Psychiatric disorders in the medical history • Risk for drug dependence as evaluated by a psychiatrist • Participation in a clinical trial in the 3 weeks preceding the study • Positive urine drug test at the screening examination or on the study days • Positive alcohol breath test at the screening examination or on the study days • Regular consumption of cannabis and inability to not consume cannabis during the study period • 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 • Known hypersensitivity to any of the components of the IMP under investigation or other study medication • History or family history of epilepsy • Pregnant or breast-feeding women • Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms) Exclusion criteria for healthy subjects: • Ocular inflammation or infection within the last 3 months • Regular use of medication that potentially could interact with THC • Abuse of alcoholic beverages or drugs • History of drug or alcohol abuse • Psychiatric disorders in the medical history • Risk for drug dependence as evaluated by a psychiatrist • Participation in a clinical trial in the 3 weeks preceding the study • Positive urine drug test at the screening examination or on the study days • Positive alcohol breath test at the screening examination or on the study days • Regular consumption of cannabis and inability to not consume cannabis during the study period • 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 • Known hypersensitivity to any of the components of the IMP under investigation or other study medication • History or family history of epilepsy • Pregnant or breast-feeding women • Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of single administration of Tetrahydrocannabinol (THC) on ocular blood flow and its regulation in patients with primary open angle glaucoma and healthy subjects.;Secondary Objective: •Flicker induced increase in retinal blood flow •Retinal vessel diameters •Retinal blood velocities •Retinal oxygen saturation •Retinal vessel density •Dronabinol concentration in plasma, tear fluid and finger sweat •Normalized blur (LSFG) • Relative flow volume (LSFG);Primary end point(s): Optic nerve head blood flow;Timepoint(s) of evaluation of this end point: Since this is a cross-over study, optic nerve head blood flow will be assessed on both study days before and after administration of dronabinol or placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Flicker induced increase in retinal blood flow • Retinal vessel diameters • Retinal blood velocities • Retinal oxygen saturation • Retinal vessel density • Dronabinol concentration in plasma, tear fluid and finger sweat • Normalized blur (LSFG) • Relative flow volume (LSFG);Timepoint(s) of evaluation of this end point: Since this is a cross-over study, optic nerve head blood flow will be assessed on both study days before and after administration of dronabinol or placebo. | — |
Countries
Austria
Contacts
Public ContactDepartment of Clinical Pharmacology
Medical University of Vienna
Outcome results
None listed