A Phase 4 interventional study of besivance and vigamox in Corneal Health and Cataract Surgery, sponsored by Ophthalmology Consultants, Ltd.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-19.
Sponsored by Ophthalmology Consultants, Ltd. · Phase 4 and Interventional
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.
136 studies on the registry are indexed under Corneal Diseases; 44 are open to participants now.
This study's enrollment of 60 is above the median of 32 across 81 interventional studies indexed under Corneal Diseases.
Browse Corneal Diseases studies →This is the only study on the registry with Ophthalmology Consultants, Ltd. as lead sponsor.
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Exclusion Criteria:
Women of childbearing potential (those who are not surgically sterilized or post menopausal) may not participate in the study if any of the following conditions exist:
ocular antibiotic
Drug: vigamox
ocular antibiotic
Drug: besivance
topical ocular antibiotic, 1 drop in study eye QID starting 3 days prior and for 7 days following cataract surgery
Also known as: besifloxacin ophthalmic suspension 0.6%
topical ocular antibiotic, 1 drop in study eye QID for 3 days prior and for 7 days following cataract surgery
Also known as: moxifloxacin hydrochloride ophthalmic solution 0.5%
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
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Besifloxacin · Moxifloxacin