Cataract Extraction Clinical Trial
Official title:
Parallel-group Study of Ocular Penetration of Peri-operative Topically Administered Fluoroquinolones With Cataract Surgery
Verified date | September 2017 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | The Wilmer Eye Institute at Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
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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