Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation - Full Text View

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:

Drug Information available for: Gatifloxacin Besifloxacin Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

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 (Adult, Senior)
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

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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


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:


Moxifloxacin Fluoroquinolones Gatifloxacin 7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid 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 Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016