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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00924729
Other study ID # NA_28692
Secondary ID
Status Completed
Phase Phase 4
First received June 5, 2009
Last updated September 21, 2017
Start date September 2009
Est. completion date November 2009

Study information

Verified date September 2017
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Moxifloxacin 0.5% ophthalmic solution
Administer moxifloxacin study drug prior to cataract surgery.
Besifloxacin 0.6% ophthalmic suspension
Administer besifloxacin study drug prior to cataract surgery.

Locations

Country Name City State
United States The Wilmer Eye Institute at Johns Hopkins University Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. approximately 3 to 4 months
Secondary 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. Approximately 3-4 months.
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