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. Aminoglycosides (i.e. gentamicin) and fluoroquinolones (i.e. ciprofloxacin) are among the most frequently used substance classes. There is evidence that topical non-antibiotic eye drops might have an effect on the nasopharyngeal mucosal flora. This seems logical due to the anatomical connection through the nasolacrimal duct and the fact that up to 80% of topically administered drug diffuse into the systemic circulation through the highly vascularized nasopharyngeal mucosa. However, in the literature no data on the effect of antibiotic eye drops on the nasal or pharyngeal microbiome are currently available. Recently, new, non-culture based techniques for assessment of the bacterial microbiome have been developed, so-called "next-generation sequencing" (NGS). NGS utilizes universal primers targeting the 16S rRNA gene, which is ubiquitous across most bacteria. With this technique, it is possible to gain information about a wide range of the bacterial microbiome and not only on pre-selected species. In the present study, NGS will be used to investigate the effect of antibiotic eye drops on the nasal and pharyngeal microbiome. For this purpose, healthy subjects will be randomized to either receive eye drops containing gentamicin, ciprofloxacin or topical lubricants as control. As secondary outcome, prevalence of bacterial resistance genes, as well as signs and symptoms of ocular surface damage will be assessed. The study will be carried out in 2 parts. Since both formulations of topical antibiotics contain benzalkonium chloride which also has a potential effect on the nasal and pharyngeal mucosal flora, it is unknown how much benzalkonium chloride would contribute to changes in the nasal microbiome after administration of topical antibiotics. To overcome this problem, first a pilot study in 20 subjects will be performed in which subjects will be randomized to receive either eye drops containing gentamicin, ciprofloxacin, preservative-containing topical lubricants or preservative-free topical lubricants. Based on the results of this pilot study, the control for the main part of the study will be chosen, depending on the effect on the bacterial microbiome. The results of the pilot study could also provide useful data to adjust the sample size for the main study part. In the main study, 60 subjects will be randomized to receive gentamicin, ciprofloxacin or lubricant eye drops. The same examinations as described above will be performed after 1 week treatment as well as 1 week and 3 months after treatment.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Aug 2019

Typical duration for phase_2

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 years study duration

Study Start

First participant enrolled

August 12, 2019

Completed

2.4 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2021

Completed

3 months until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2023

Completed

Last Updated

May 16, 2025

Status Verified

March 1, 2023

Enrollment Period

4 years

First QC Date

December 29, 2021

Last Update Submit

May 13, 2025

Conditions

Nasal and Pharyngeal Microbiome

Outcome Measures

Primary Outcomes (1)

Nasal bacterial microbiome
16S rRNA gene sequencing
change after 1 week treatment

Secondary Outcomes (4)

Pharyngeal bacterial microbiome
change after 1 week treatment
Antibiotic resistance gene prevalence
change after 1 week treatment
Minimum inhibitory concentrations for gentamicin and ciprofloxacin
change after 1 week treatment
Tear film thickness
change after 1 week treatment