At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Comparison of Peak Aqueous Penetration of Acuvail, Xibrom, and Nevanac in Patients Undergoing Phacoemulsification
In Brief
A Phase 4 clinical trial evaluating Ketorolac Tromethamine 0.45%, bromfenac 0.09%, and 1 other intervention for Cataracts. Completed, enrolled 126 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery
One day pre operative 1 drop BID then 3 doses pre op day of surgery
One drop BID, 1 day pre operative and then 3 doses the day of surgery