Phase 4
Completed N=50
Study of Ocular Penetration of Topically Administered Fluoroquinolones
Cataract Extraction
Source: ClinicalTrials.gov NCT00924729 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcomePrimary: Aqueous Humor Concentration of Study Drug — 1.6108; 0.0312 µg/ml — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aqueous Humor Concentration of Study Drug |
1.6108; 0.0312 | <0.0001 sig |
| SECONDARY Disk Diffusion Assay of Collected Aqueous Humor |
— | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00924729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.