Parallel-group Study of Ocular Penetration of Peri-operative Topically Administered Fluoroquinolones With Cataract Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Aqueous Humor Concentration of Study Drug
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- 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.
Arms & Interventions
Moxifloxacin 0.5% ophthalmic solution
Intervention: Moxifloxacin 0.5% ophthalmic solution (Drug)
Besifloxacin 0.6% ophthalmic suspension
Intervention: Besifloxacin 0.6% ophthalmic suspension (Drug)
Outcomes
Primary Outcomes
Aqueous Humor Concentration of Study Drug
Time Frame: approximately 3 to 4 months
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 Outcomes
- Disk Diffusion Assay of Collected Aqueous Humor(Approximately 3-4 months.)