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

Sponsor

Bausch & Lomb Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT00905762

Collaborator

(none)

119

Enrollment

Location

Arms

Duration (Months)

116.8

Patients Per Site Per Month

Study Details

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

Study Type:

Interventional

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 :

Mar 1, 2009

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

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 Names: 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.

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 Names:

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. [Biopsies collected at specified time points from 15 minutes to 24 hours]

Secondary Outcome Measures

Visual acuity [Day -14 through Day 6(+/-1)]
Slit Lamp Biomicroscopy [Day -14 through Day 6 (+/-)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb Incorporated	Rochester	New York	United States	14609

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators

Study Director: Timothy Comstock, OD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT00905762

Other Study ID Numbers:

First Posted:

May 21, 2009

Last Update Posted:

Dec 9, 2011

Last Verified:

Dec 1, 2011

Keywords provided by Bausch & Lomb Incorporated

pharmacokinetics

Additional relevant MeSH terms:

Moxifloxacin

Gatifloxacin

Besifloxacin

Study Results

No Results Posted as of Dec 9, 2011