Status:
COMPLETED
Study of Ocular Penetration of Topically Administered Fluoroquinolones
Lead Sponsor:
Johns Hopkins University
Conditions:
Cataract Extraction
Eligibility:
All Genders
21+ years
Phase:
PHASE4
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 top...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00924729
Start Date
September 1 2009
End Date
November 1 2009
Last Update
October 24 2017
Active Locations (1)
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1
The Wilmer Eye Institute at Johns Hopkins University
Baltimore, Maryland, United States, 21287