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

NCT ID: NCT00905762

Last Updated: 2011-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Besifloxacin

Besifloxacin one drop instilled into study eye.

Group Type EXPERIMENTAL

Besifloxacin

Intervention Type DRUG

Besifloxacin 0.6% one drop instilled into study eye at visit 2.

Gatifloxacin

Gatifloxacin one drop instilled into study eye.

Group Type ACTIVE_COMPARATOR

Gatifloxacin

Intervention Type DRUG

Gatifloxacin 0.3% one drop instilled into study eye at visit 2.

Moxifloxacin

Moxifloxacin one drop instilled into study eye.

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Moxifloxacin 0.5% one drop instilled into study eye at visit 2.

Interventions

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Gatifloxacin

Gatifloxacin 0.3% one drop instilled into study eye at visit 2.

Intervention Type DRUG

Moxifloxacin

Moxifloxacin 0.5% one drop instilled into study eye at visit 2.

Intervention Type DRUG

Besifloxacin

Besifloxacin 0.6% one drop instilled into study eye at visit 2.

Intervention Type DRUG

Other Intervention Names

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Besivance

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Comstock, OD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Bausch & Lomb Incorporated

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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608

Identifier Type: -

Identifier Source: org_study_id