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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ophthalmology Consultants, Ltd.
• Collaborators: Bausch & Lomb Incorporated; Ophthalmology Associates, St Louis
• Treatments: 7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid; Anti-Bacterial Agents; Antibiotics, Antitubercular; Besifloxacin; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ophthalmic Solutions

Criteria

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 acuityETDRS 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