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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00905762

Run by

Bausch & Lomb Incorporated

People needed

119

Starts

2009-03-01

Expected to finish

2009-04-01

Last updated by the study team

2011-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bausch & Lomb Incorporated — Rochester, New York, United States

Full record on ClinicalTrials.gov

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