2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery

Completed · Phase 4

Conditions studied: Corneal Health, Cataract Surgery

In brief

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.

Key facts

Study ID

NCT01455233

Run by

Ophthalmology Consultants, Ltd.

People needed

60

Starts

2010-09-01

Expected to finish

2011-02-01

Last updated by the study team

2011-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ophthalmology Associates — St Louis, Missouri, United States
• Ophthalmology Consultants, Ltd — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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