Study of Ocular Penetration of Topically Administered Fluoroquinolones

Study Overview
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Brief Summary
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This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery.

Official Title
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Parallel-group Study of Ocular Penetration of Peri-operative Topically Administered Fluoroquinolones With Cataract Surgery

Conditions
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Cataract Extraction

Intervention / Treatment
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* Drug: Moxifloxacin 0.5% ophthalmic solution
* Drug: Besifloxacin 0.6% ophthalmic suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have a visually significant cataract and are planning to have cataract surgery. Subjects who are willing/able and have signed informed consent approved by the Institutional Review Board. Exclusion Criteria: Subjects who have a known hypersensitivity, allergy, or contraindication to any fluoroquinolone medication, in any form. Subjects who signs of ocular infection or active inflammation in the study eye. Subjects who have corneal pathology, including epithelial defect, corneal scarring, or severe dry eye syndrome. Subjects who have used any disallowed medication (including antibiotics) during the time period designated as described in the protocol. Subjects who have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and is likely to increase the risk of infection to the patient or confound the results of the study. Subjects who are pregnant (or suspect to be pregnant) or nursing/lactating. Subjects who have participated in any study of an investigational drug or device within 30 days prior to enrollment.

Ages Eligible for Study
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Minimum Age: 21 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moxifloxacin 0.5% ophthalmic solution<br> | Drug: Moxifloxacin 0.5% ophthalmic solution<br>* Administer moxifloxacin study drug prior to cataract surgery.<br>* Other names: Vigamox;|
| Active Comparator: Besifloxacin 0.6% ophthalmic suspension<br> | Drug: Besifloxacin 0.6% ophthalmic suspension<br>* Administer besifloxacin study drug prior to cataract surgery.<br>* Other names: Besivance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aqueous Humor Concentration of Study Drug | Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chromatography (HPLC)-tandem mass spectrometry method. | approximately 3 to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disk Diffusion Assay of Collected Aqueous Humor | A disk diffusion assay was performed to determine the relative antimicrobial activity of the study drug in the aqueous humor. The reference organism used was a clinical isolate of S. epidermidis that will be grown and adjusted to a 0.5 MacFarland turbidity standard. The standardized suspension was inoculated onto a Mueller-Hinton II agar. A sample of the aqueous humor was applied to 6 mm sterile disks, dried, and then placed onto the inoculated Mueller-Hinton II agar plates. The plates were incubated for 24 hours at 35° C. The zone sizes were then recorded. | Approximately 3-4 months. |