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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Moxifloxacin; Drug: Besifloxacin; Drug: Gatifloxacin

• Registration Number: NCT00905762
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxifloxacin	Moxifloxacin	Moxifloxacin one drop instilled into study eye.
Besifloxacin	Besifloxacin	Besifloxacin one drop instilled into study eye.
Gatifloxacin	Gatifloxacin	Gatifloxacin one drop instilled into study eye.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bausch & Lomb Incorporated; 🇺🇸 Rochester, New York, United States