Study of Ocular Penetration of Topically Administered Fluoroquinolones



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:21 - Any
Updated:10/26/2017
Start Date:September 2009
End Date:November 2009

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Parallel-group Study of Ocular Penetration of Peri-operative Topically Administered Fluoroquinolones With Cataract Surgery

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.


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.
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