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

Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Gatifloxacin (Drug); Moxifloxacin (Drug); Besifloxacin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bausch & Lomb Incorporated

Official(s) and/or principal investigator(s):
Timothy Comstock, OD, Study Director, Affiliation: Bausch & Lomb Incorporated


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening

Primary outcome: Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue.

Secondary outcome:

Visual acuity

Slit Lamp Biomicroscopy


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Bausch & Lomb Incorporated, Rochester, New York 14609, United States
Additional Information

Starting date: March 2009
Last updated: December 7, 2011

Page last updated: August 23, 2015

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