Study of Ocular Penetration of Topically Administered Fluoroquinolones

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00924729
First received: June 5, 2009
Last updated: May 25, 2010
Last verified: November 2009
  Purpose

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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924729

Locations
United States, Maryland
The Wilmer Eye Institute at Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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
ClinicalTrials.gov 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
Cataract
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Wounds and Injuries
Wounds, Penetrating
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Moxifloxacin
Fluoroquinolones
Besifloxacin
Norgestimate, ethinyl estradiol drug combination
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014