EUCTR2019-003089-42-AT进行中（未招募）1 期
The effect of Tetrahydrocannabinol on ocular hemodynamics in patients with primary open angle glaucoma- A Phase II Study - ONH Blood Flow THC Glaucoma
Medical University of Vienna, Department of Clinical Pharmacology0 个研究点目标入组 50 人开始时间: 2019年11月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 < 10dB
- •Informed consent signed and dated
- •Patient aged = 18 years old
- •Ametropia = 6 diopters
- •Normal findings in the medical history and physical examination including ECG unless the investigator considers an abnormality to be clinically irrelevant
- •Normal findings in the laboratory testing unless the investigator considers an abnormality to be clinically irrelevant
- •Nonsmokers
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •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)
研究者
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