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

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

Layout table for study information

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

Resource links provided by the National Library of Medicine

Drug Information available for: Gatifloxacin Besifloxacin Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Arms and Interventions

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

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 (+/-) ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information

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

Information from the National Library of Medicine

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

Layout table for location information

United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators

Layout table for investigator information

Study Director:	Timothy Comstock, OD	Bausch & Lomb Incorporated

More Information

Layout table for additonal information

Responsible Party:	Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:	NCT00905762 History of Changes
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:

Layout table for MeSH terms

Moxifloxacin Gatifloxacin Besifloxacin Fluoroquinolones Norgestimate, ethinyl estradiol drug combination Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action	Antineoplastic Agents Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Ophthalmic Solutions Pharmaceutical Solutions Nucleic Acid Synthesis Inhibitors

To Top