Study of Ocular Penetration of Topically Administered Fluoroquinolones

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract Extraction
• Intervention / Treatment: Drug: Moxifloxacin 0.5% ophthalmic solution; Drug: Besifloxacin 0.6% ophthalmic suspension

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Wilmer Eye Institute at Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Walter J. Stark, M.D., The Wilmer Eye Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: June 5, 2009
• First Submitted That Met QC Criteria: June 17, 2009
• First Posted (Estimate): June 19, 2009

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: September 21, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Lens Diseases; Facial Injuries; Wounds, Penetrating; Eye Injuries; Cataract; Eye Injuries, Penetrating; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Pharmaceutical Solutions; Moxifloxacin; Ophthalmic Solutions; Besifloxacin
• Other Study ID Numbers: NA_28692