Status:
COMPLETED
The Effect of Antibiotic Eye Drops on the Nasal Microbiome in Healthy Subjects
Lead Sponsor:
Medical University of Vienna
Conditions:
Nasal and Pharyngeal Microbiome
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
Ophthalmic topical antibiotics are commonly prescribed in clinical practice for several indications such as bacterial conjunctivitis, keratitis, blepharitis, dacryocystitis and also as prophylaxis. Am...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
August 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05287425
Start Date
August 12 2019
End Date
August 28 2023
Last Update
May 16 2025
Active Locations (1)
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1
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Vienna, Austria, 1090