Study of Ocular Penetration of Topically Administered Fluoroquinolones

Phase 4

Completed

• Conditions: Cataract Extraction
• Interventions: Drug: Besifloxacin 0.6% ophthalmic suspension; Drug: Moxifloxacin 0.5% ophthalmic solution

• Registration Number: NCT00924729
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-17
• Study First Posted: 2009-06-19
• Study Start: 2009-09
• Primary Completion: 2009-10
• Study Completion: 2009-11
• Results First Submitted: 2010-02-24
• Results First Submitted QC: 2010-02-24
• Results First Posted: 2010-03-11
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-21
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Besifloxacin 0.6% ophthalmic suspension	Besifloxacin 0.6% ophthalmic suspension	-
Moxifloxacin 0.5% ophthalmic solution	Moxifloxacin 0.5% ophthalmic solution	-

Primary Outcome Measures

Name	Time	Method
Aqueous Humor Concentration of Study Drug	approximately 3 to 4 months	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.

Secondary Outcome Measures

Name	Time	Method
Disk Diffusion Assay of Collected Aqueous Humor	Approximately 3-4 months.	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.

Trial Locations

Locations (1)

The Wilmer Eye Institute at Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States