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Completed

NCT Number: NCT00924729

Study of Ocular Penetration of Topically Administered Fluoroquinolones

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.

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Key information

Conditions

Cataract Extraction

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Wilmer Eye Institute at Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moxifloxacin 0.5% ophthalmic solution

Drug

Administer moxifloxacin study drug prior to cataract surgery.

Other names: Vigamox

Besifloxacin 0.6% ophthalmic suspension

Drug

Administer besifloxacin study drug prior to cataract surgery.

Other names: Besivance

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 19, 2009
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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