search
Back to results

Study of Ocular Penetration of Topically Administered Fluoroquinolones

Primary Purpose

Cataract Extraction

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Moxifloxacin 0.5% ophthalmic solution
Besifloxacin 0.6% ophthalmic suspension
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract Extraction

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Wilmer Eye Institute at Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Moxifloxacin 0.5% ophthalmic solution

Besifloxacin 0.6% ophthalmic suspension

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 5, 2009
Last Updated
September 21, 2017
Sponsor
Johns Hopkins University
search

1. Study Identification

Unique Protocol Identification Number
NCT00924729
Brief Title
Study of Ocular Penetration of Topically Administered Fluoroquinolones
Official Title
Parallel-group Study of Ocular Penetration of Peri-operative Topically Administered Fluoroquinolones With Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Extraction

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moxifloxacin 0.5% ophthalmic solution
Arm Type
Active Comparator
Arm Title
Besifloxacin 0.6% ophthalmic suspension
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin 0.5% ophthalmic solution
Other Intervention Name(s)
Vigamox
Intervention Description
Administer moxifloxacin study drug prior to cataract surgery.
Intervention Type
Drug
Intervention Name(s)
Besifloxacin 0.6% ophthalmic suspension
Other Intervention Name(s)
Besivance
Intervention Description
Administer besifloxacin study drug prior to cataract surgery.
Primary Outcome Measure Information:
Title
Aqueous Humor Concentration of Study Drug
Description
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.
Time Frame
approximately 3 to 4 months
Secondary Outcome Measure Information:
Title
Disk Diffusion Assay of Collected Aqueous Humor
Description
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.
Time Frame
Approximately 3-4 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter J. Stark, M.D.
Organizational Affiliation
The Wilmer Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Wilmer Eye Institute at Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Ocular Penetration of Topically Administered Fluoroquinolones

We'll reach out to this number within 24 hrs