Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation
Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Gatifloxacin (Drug); Moxifloxacin (Drug); Besifloxacin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bausch & Lomb Incorporated Official(s) and/or principal investigator(s): Timothy Comstock, OD, Study Director, Affiliation: Bausch & Lomb Incorporated
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening
Primary outcome: Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue.
Secondary outcome: Visual acuitySlit Lamp Biomicroscopy
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Bausch & Lomb Incorporated, Rochester, New York 14609, United States
Additional Information
Starting date: March 2009
Last updated: December 7, 2011
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