Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects

Study Overview
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Brief Summary
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This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation in subjects undergoing cataract surgery.

Official Title
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An Open-Label, Randomized Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects After a Single Topical Dose

Conditions
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Cataract Extraction

Intervention / Treatment
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* Drug: Besifloxacin hydrochloride
* Drug: moxifloxacin hydrochloride
* Drug: gatifloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are a candidate for a routine, uncomplicated, primary cataract extraction. Subjects who, in the Investigator's opinion, have potential for postoperative best corrected Snellen visual acuity of at least 20/200 in the study eye. Exclusion Criteria: Subjects who have a known sensitivity, contraindication, or allergy to the study medication(s) or their components. Subjects who had any corneal refractive surgery in the study eye. Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study. Subjects who had ocular surgery in the study eye, including laser procedures, within the past 6 months. Subjects who have taken any topical ocular medication in the study eye, other than those required by the protocol and permitted for surgery, during the 24 hours prior to the study medication being instilled. Subjects who use any antibiotics (e.g., systemic or topical) within the 7 days prior to the surgery date. Subjects who are monocular.

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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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Besifloxacin<br>Besifloxacin ophthalmic suspension | Drug: Besifloxacin hydrochloride<br>* Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.<br>* Other names: Besivance;|
| Active Comparator: Moxifloxacin<br>Vigamox (moxifloxacin ophthalmic solution, 0.5%) | Drug: moxifloxacin hydrochloride<br>* Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.<br>* Other names: Vigamox;|
| Active Comparator: Gatifloxacin<br>Zymar (gatifloxacin ophthalmic solution, 0.3%) | Drug: gatifloxacin<br>* Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.<br>* Other names: Zymar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Aqueous Humor Drug Concentration. | An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation. | Visit 2, 1-14 days following screening visit | 

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