NCT01455233

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

Phase IV Study: A Prospective Two-Site Study to Evaluate the Safety and Tolerance of Besivance Versus Vigamox Prophylactically Pre and Post Operatively in Subjects Undergoing Routine Cataract Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ophthalmology Consultants, Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Corneal Health
• Cataract Surgery

Interventions

Type	Name	Description
DRUG	besivance	topical ocular antibiotic, 1 drop in study eye QID starting 3 days prior and for 7 days following cataract surgery
DRUG	vigamox	topical ocular antibiotic, 1 drop in study eye QID for 3 days prior and for 7 days following cataract surgery

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2011-10-19
• Last updated: 2011-10-19

Locations

2 sites across 1 country: United States