Study of Ocular Penetration of Topically Administered Fluoroquinolones

This study has been completed.
Information provided by:
Johns Hopkins University Identifier:
First received: June 5, 2009
Last updated: May 25, 2010
Last verified: November 2009

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 Intervention Phase
Cataract Extraction
Drug: Moxifloxacin 0.5% ophthalmic solution
Drug: Besifloxacin 0.6% ophthalmic suspension
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Parallel-group Study of Ocular Penetration of Peri-operative Topically Administered Fluoroquinolones With Cataract Surgery

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Aqueous Humor Concentration of Study Drug [ Time Frame: approximately 3 to 4 months ] [ Designated as safety issue: No ]
    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:
  • Disk Diffusion Assay of Collected Aqueous Humor [ Time Frame: Approximately 3-4 months. ] [ Designated as safety issue: No ]
    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.

Enrollment: 50
Study Start Date: September 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00924729

United States, Maryland
The Wilmer Eye Institute at Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Walter J. Stark, M.D. The Wilmer Eye Institute
  More Information

No publications provided

Responsible Party: Walter J. Stark, M.D./Professor of Ophthalmology, The Wilmer Eye Institute Identifier: NCT00924729     History of Changes
Other Study ID Numbers: NA_28692
Study First Received: June 5, 2009
Results First Received: February 24, 2010
Last Updated: May 25, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Eye Injuries, Penetrating
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Wounds and Injuries
Wounds, Penetrating
Lens Diseases
Eye Diseases
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 17, 2014