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 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:

1. they are breast feeding

2. they have a positive urine pregnancy test at screening

3. they are not willing to undergo a urine pregnancy test upon entering or exiting
the study

4. they intend to become pregnant during the duration of the study; or,

5. they do not agree to use adequate birth control methods for the duration of the
study