The effect of antibiotic eye drops on the nasal microbiome in healthy subjects

Phase 1

• Conditions: healthy volunteers; Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

• Registration Number: EUCTR2018-002578-37-AT
• Lead Sponsor: Medical University of Vienna, Department of Clinical Pharmacology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-17
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

•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

Exclusion Criteria

•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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified