Study of Ocular Penetration of Topically Administered Fluoroquinolones
Completed · Phase 4
Conditions studied: Cataract Extraction
In brief
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.
Key facts
- Study ID
- NCT00924729
- Run by
- Johns Hopkins University
- People needed
- 50
- Starts
- 2009-09-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2017-10-24
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Wilmer Eye Institute at Johns Hopkins University — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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