NCT01021761

A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification

A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Frank A. Bucci, Jr., M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.

Conditions

• Cataracts

Interventions

Type	Name	Description
DRUG	Ketorolac Tromethamine	ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
DRUG	Bromfenac	Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
DRUG	nepafenac	drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2009-11-30
• Last updated: 2011-08-31
• Results posted: 2011-08-26