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

This study has been completed.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated Identifier:
First received: April 3, 2009
Last updated: December 7, 2011
Last verified: December 2011
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.

Condition Intervention Phase
Drug: Gatifloxacin
Drug: Moxifloxacin
Drug: Besifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
Official Title: A Single-Center, Randomized, Masked Study Comparing the Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After a Single Topical Instillation

Resource links provided by NLM:

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue. [ Time Frame: Biopsies collected at specified time points from 15 minutes to 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: Day -14 through Day 6(+/-1) ] [ Designated as safety issue: No ]
  • Slit Lamp Biomicroscopy [ Time Frame: Day -14 through Day 6 (+/-) ] [ Designated as safety issue: No ]

Enrollment: 119
Study Start Date: March 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Besifloxacin
Besifloxacin one drop instilled into study eye.
Drug: Besifloxacin
Besifloxacin 0.6% one drop instilled into study eye at visit 2.
Other Name: Besivance
Active Comparator: Gatifloxacin
Gatifloxacin one drop instilled into study eye.
Drug: Gatifloxacin
Gatifloxacin 0.3% one drop instilled into study eye at visit 2.
Active Comparator: Moxifloxacin
Moxifloxacin one drop instilled into study eye.
Drug: Moxifloxacin
Moxifloxacin 0.5% one drop instilled into study eye at visit 2.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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.
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Please refer to this study by its identifier: NCT00905762

United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Study Director: Timothy Comstock, OD Bausch & Lomb Incorporated
  More Information

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00905762     History of Changes
Other Study ID Numbers: 608 
Study First Received: April 3, 2009
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:

Additional relevant MeSH terms:
7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid
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