Study of Ocular Penetration of Topically Administered Fluoroquinolones

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2009

Interventions

  • Drug: Moxifloxacin 0.5% ophthalmic solution
    • Administer moxifloxacin study drug prior to cataract surgery.
  • Drug: Besifloxacin 0.6% ophthalmic suspension
    • Administer besifloxacin study drug prior to cataract surgery.

Arms, Groups and Cohorts

  • Active Comparator: Moxifloxacin 0.5% ophthalmic solution
  • Active Comparator: Besifloxacin 0.6% ophthalmic suspension

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Walter J. Stark, M.D., Principal Investigator, The Wilmer Eye Institute

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.