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

The effect of antibiotic eye drops on the nasal microbiome in healthy subjects - AB Agtt Nasal Microbiome

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002578-37-AT

Enrollment

Registered

2018-07-17

Start date

2019-04-25

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers

Interventions

Trade Name: Gentax eye drops Pharmaceutical Form: Eye drops INN or Proposed INN: GENTAMICIN SULFATE CAS Number: 1405-41-0 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of 1 week treatment with two different antibiotic eye drops on the nasal microbiome in healthy subjects.;Primary end point(s): Changes in the nasal bacterial microbiome; Timepoint(s) of evaluation of this end point: after 1 week treatment 3 months after end of treatment (main study only) ; Secondary Objective: To investigate the effect of 1 week treatment with two different antibiotic eye drops on: • Antibiotic resistance gene prevalence and MICs for the used antibiotics • Tear film thickness • Tear Osmolarity • Fluorescein and lissamine green staining • Tear Break Up Time • Schirmer I test • Ocular Surface Disease Index (OSDI)	—

Measure

Time frame

Main Objective: To investigate the effect of 1 week treatment with two different antibiotic eye drops on the nasal microbiome in healthy subjects.;Primary end point(s): Changes in the nasal bacterial microbiome; Timepoint(s) of evaluation of this end point: after 1 week treatment 3 months after end of treatment (main study only) ; Secondary Objective: To investigate the effect of 1 week treatment with two different antibiotic eye drops on: • Antibiotic resistance gene prevalence and MICs for the used antibiotics • Tear film thickness • Tear Osmolarity • Fluorescein and lissamine green staining • Tear Break Up Time • Schirmer I test • Ocular Surface Disease Index (OSDI)

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: after 1 week treatment 3 months after end of treatment (main study only) ; Secondary end point(s): Changes in: • Antibiotic resistance gene prevalence • Minimum inhibitory concentrations for gentamicin and ciprofloxacin • Tear film thickness • Tear Osmolarity • Fluorescein and lissamine green staining • Tear Break Up Time • Schirmer I test • Ocular Surface Disease Index (OSDI)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: after 1 week treatment 3 months after end of treatment (main study only) ; Secondary end point(s): Changes in: • Antibiotic resistance gene prevalence • Minimum inhibitory concentrations for gentamicin and ciprofloxacin • Tear film thickness • Tear Osmolarity • Fluorescein and lissamine green staining • Tear Break Up Time • Schirmer I test • Ocular Surface Disease Index (OSDI)

—

Countries

Austria

Contacts

Public ContactDepartment of Clinical Pharmacology

Medical University of Vienna

klin-pharmakologie@meduniwien.ac.at+4314040029810

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026