2-Site Safety Study of Besivance Versus Vigamox Prophylactically in 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.

Inclusion criteria

• Men or woen of any race, 18 years or older who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens
• Study eye of patients who, in the opinion of the investigator, will experience improvement in visual acuity following surgery
• Patients who are able to understand and sign an informed consent form that has been approved by an IRB

Exclusion criteria

• Planned multiple procedures during cataract/IOL implantation surgery. Note: A planned limbal relaxing incision may be performed for the correction of astigmatism
• Use of topical ocular or systemic antibiotics within 14 days prior to surgery and through study exit
• History of or Fuch's Corneal Endothelial Dystrophy
• Any ocular inflammation (aqueous cells or flare greater than Grade 0) or ocular pain in the study eye that is present during the baseline visit.
• Recent (within 6 months) ocular trama to the operative eye (this includes intraocular surgery)
• A history of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye
• Currently diagnosed uncontrolled glaucoma in the operative eye
• Congenital ocular anomaly (eg, aniridia, congenital cataract) in the operative eye
• A visually nonfunctional fellow eye defined as a best corrected visual acuity </= 35 ETDRS letters (20/200 Snellen equivalent) or worse
• Participation in any other investigational drug or device study within 30 days before cataract surgery
• Known or suspected allergy or hypersensitivity to any component of either test article
• 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:

• they are breast feeding
• they have a positive urine pregnancy test at screening
• they are not willing to undergo a urine pregnancy test upon entering or exiting the study
• they intend to become pregnant during the duration of the study; or,
• they do not agree to use adequate birth control methods for the duration of the study