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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00905762
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : December 9, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Gatifloxacin Drug: Moxifloxacin Drug: Besifloxacin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : March 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

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Arms and Interventions
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Arm Intervention/treatment
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.


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905762


Locations
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United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Timothy Comstock, OD Bausch & Lomb Incorporated
More Information
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00905762    
Other Study ID Numbers: 608
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: December 9, 2011
Last Verified: December 2011
Keywords provided by Bausch & Lomb Incorporated:
pharmacokinetics
Additional relevant MeSH terms:
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Moxifloxacin
Gatifloxacin
Besifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
 Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Ophthalmic Solutions
Pharmaceutical Solutions