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
  Purpose

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
Healthy
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905762

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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov 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:
pharmacokinetics

Additional relevant MeSH terms:
Gatifloxacin
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014