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Study of Ocular Penetration of Topically Administered Fluoroquinolones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00924729
Recruitment Status : Completed
First Posted : June 19, 2009
Results First Posted : March 11, 2010
Last Update Posted : October 24, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cataract Extraction Drug: Moxifloxacin 0.5% ophthalmic solution Drug: Besifloxacin 0.6% ophthalmic suspension Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Parallel-group Study of Ocular Penetration of Peri-operative Topically Administered Fluoroquinolones With Cataract Surgery
Study Start Date : September 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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 Name: Vigamox

Active Comparator: Besifloxacin 0.6% ophthalmic suspension Drug: Besifloxacin 0.6% ophthalmic suspension
Administer besifloxacin study drug prior to cataract surgery.
Other Name: Besivance

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00924729

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United States, Maryland
The Wilmer Eye Institute at Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Walter J. Stark, M.D. The Wilmer Eye Institute
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Responsible Party: Johns Hopkins University Identifier: NCT00924729    
Other Study ID Numbers: NA_28692
First Posted: June 19, 2009    Key Record Dates
Results First Posted: March 11, 2010
Last Update Posted: October 24, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Eye Injuries, Penetrating
Lens Diseases
Eye Diseases
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Wounds, Penetrating
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents