Study of Ocular Penetration of Topically Administered Fluoroquinolones

Johns Hopkins University

Status and phase

Completed

Phase 4

Conditions

Cataract Extraction

Treatments

Drug: Besifloxacin 0.6% ophthalmic suspension

Drug: Moxifloxacin 0.5% ophthalmic solution

Study type

Interventional

Funder types

Other

Identifiers

NCT00924729

NA_28692

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

21+ years old

Volunteers

No 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.