Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation

A Single-Center, Randomized, Masked Study Comparing the Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After a Single Topical Instillation

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00905762

Enrollment

119

Registered

2009-05-21

Start date

2009-03-31

Completion date

2009-04-30

Last updated

2011-12-09

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

Conditions

Healthy

Keywords

pharmacokinetics

Brief summary

The purpose of this study is to assess the concentration of besifloxacin compared to gatifloxacin and moxifloxacin in human conjunctival tissue, following a single drop of the drug instilled topically into the study eye. Conjunctival biopsies will be performed at specified time points, followed by the use of loteprednol etabonate/tobramycin ophthalmic suspension four times a day for 5 days.

Interventions

DRUGGatifloxacin

Gatifloxacin 0.3% one drop instilled into study eye at visit 2.

DRUGMoxifloxacin

Moxifloxacin 0.5% one drop instilled into study eye at visit 2.

DRUGBesifloxacin

Besifloxacin 0.6% one drop instilled into study eye at visit 2.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Willing to avoid all disallowed medications for the appropriate washout periods. * Have a best corrected visual acuity of 0.60 logMAR or better in each eye as measured using an ETDRS chart.

Exclusion criteria

* Have a known allergy and/or sensitivity to the test articles or its components or any therapy associated with the trial. * Monocular. * Have previously participated in a conjunctival biopsy study. * Be currently enrolled in an investigational drug or device study or have uses of an investigational drug or device within 30 days of entry into this study. * have a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Design outcomes

Primary

Measure	Time frame
Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue.	Biopsies collected at specified time points from 15 minutes to 24 hours

Secondary

Measure	Time frame
Visual acuity	Day -14 through Day 6(+/-1)
Slit Lamp Biomicroscopy	Day -14 through Day 6 (+/-)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026