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

Study Overview
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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.

Official Title
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A Single-Center, Randomized, Masked Study Comparing the Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After a Single Topical Instillation

Conditions
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Healthy

Intervention / Treatment
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* Drug: Gatifloxacin
* Drug: Moxifloxacin
* Drug: Besifloxacin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Besifloxacin<br>Besifloxacin one drop instilled into study eye. | Drug: Besifloxacin<br>* Besifloxacin 0.6% one drop instilled into study eye at visit 2.<br>* Other names: Besivance;|
| Active Comparator: Gatifloxacin<br>Gatifloxacin one drop instilled into study eye. | Drug: Gatifloxacin<br>* Gatifloxacin 0.3% one drop instilled into study eye at visit 2.<br>|
| Active Comparator: Moxifloxacin<br>Moxifloxacin one drop instilled into study eye. | Drug: Moxifloxacin<br>* Moxifloxacin 0.5% one drop instilled into study eye at visit 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue. |  | Biopsies collected at specified time points from 15 minutes to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | Day -14 through Day 6(+/-1) | 
| Slit Lamp Biomicroscopy |  | Day -14 through Day 6 (+/-) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics