drugset / Trial / NCT01001806

A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification

NCT01001806

Phase 4 Completed 126 enrolled Frank A. Bucci, Jr., M.D. Allergan · collab
RandomizedParallel-groupSingle-blindTreatment

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 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.

Timeline

Start
2009-10
Primary completion
2009-12
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bromfenac Other / unclassified 0.09 %
Comparator Ketorolac Tromethamine Small molecule 0.45 %
Comparator Nepafenac Other / unclassified 0.1 %

Indications