Clinical Trial: Study of Ocular Penetration of Topically Administered Fluoroquinolones

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Johns Hopkins University

Current Primary Outcome: Aqueous Humor Concentration of Study Drug [ Time Frame: 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.


Original Primary Outcome: Aqueous Humor Concentration of Study Drug [ Time Frame: The aqueous humor sample will be obtained at the onset of cataract surgery ]

Current Secondary Outcome: Disk Diffusion Assay of Collected Aqueous Humor [ Time Frame: 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.


Original Secondary Outcome:

Information By: Johns Hopkins University

Dates:
Date Received: June 5, 2009
Date Started: September 2009
Date Completion:
Last Updated: May 25, 2010
Last Verified: November 2009