Study of Ocular Penetration of Topically Administered Fluoroquinolones

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: 7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid; Besifloxacin; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ophthalmic Solutions

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.