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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00905762
First received: April 3, 2009
Last updated: December 7, 2011
Last verified: December 2011

April 3, 2009
December 7, 2011
March 2009
April 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00905762 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation
A Single-Center, Randomized, Masked Study Comparing the Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After a Single Topical Instillation

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
Healthy
  • Drug: Gatifloxacin
    Gatifloxacin 0.3% one drop instilled into study eye at visit 2.
  • Drug: Moxifloxacin
    Moxifloxacin 0.5% one drop instilled into study eye at visit 2.
  • Drug: Besifloxacin
    Besifloxacin 0.6% one drop instilled into study eye at visit 2.
    Other Name: Besivance
  • Experimental: Besifloxacin
    Besifloxacin one drop instilled into study eye.
    Intervention: Drug: Besifloxacin
  • Active Comparator: Gatifloxacin
    Gatifloxacin one drop instilled into study eye.
    Intervention: Drug: Gatifloxacin
  • Active Comparator: Moxifloxacin
    Moxifloxacin one drop instilled into study eye.
    Intervention: Drug: Moxifloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
April 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00905762
608
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Timothy Comstock, OD Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP