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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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: Day -14 through Day 6(+/-1) ]
  • Slit Lamp Biomicroscopy [ Time Frame: Day -14 through Day 6 (+/-) ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  Contacts and Locations
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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

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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Physiological Effects of Drugs processed this record on May 22, 2017