EUCTR2018-002578-37-AT进行中（未招募）1 期
The effect of antibiotic eye drops on the nasal microbiome in healthy subjects - AB Agtt Nasal Microbiome
Medical University of Vienna, Department of Clinical Pharmacology0 个研究点目标入组 80 人开始时间: 2018年7月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
入选标准
- •Men and women aged between 18 and 45 years
- •Normal ophthalmic findings
- •Tear Break Up Time >10 seconds
- •Schirmer I Test > 10mm/5min
- •Ametropia = 6 diopters
- •No use of topical eye or nasal drops in the last 3 months
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Regular use of medication, abuse of alcoholic beverages or drugs
- •Participation in a clinical trial in the 3 weeks preceding the study
- •Treatment in the previous 3 weeks with any drug (except intake of hormonal contraceptives)
- •Treatment with topical or systemic antibiotics within 8 weeks before inclusion
- •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
- •Known hypersensitivity to any of the components of the IMP under investigation or other study medication
- •Pregnant or breast-feeding women
- •Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (i.e. oral contraceptives, intra-uterine device, contraceptive implant or condoms)
研究者
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