The purpose of this study is to demonstrate that Besivance is equal to Vigamox in safety and tolerance when used prophylactically in subjects undergoing routine cataract surgery.
Subjects will be assigned to receive either Besivance or Vigamox (1:1) to be administered as 1 drop in the study eye 4 times daily starting 3 days prior to cataract surgery and continuing for 7 days post-operatively. Sixty subjects (30 from Ophthalmology Consultants and 30 from Ophthalmology Associates) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
60
Ophthalmology Associates
St Louis, Missouri, United States
Ophthalmology Consultants, Ltd
St Louis, Missouri, United States
corneal health
Endothelial Cell Count (day 7, day 28) Pachymetry (day 7, day 28) Corneal Fluorescein Staining (day 7, day 28) Biomicroscopy (day 1, day 7, day 28)
Time frame: through day 28 post op
subject tolerance
reported adverse events
Time frame: day - 3 through day 28
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