CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 126 enrolled
Drug / intervention
Ketorolac Tromethamine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01021761
NCT01021761Phase 4Completed
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A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification

Frank A. Bucci, Jr., M.D.·interventional·Posted Nov 30, 2009·Updated Aug 31, 2011

In Brief

A Phase 4 clinical trial evaluating Ketorolac Tromethamine, Bromfenac, and 1 other intervention for Cataracts. Completed, enrolled 126 participants.

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataracts
Countries--
CollaboratorsAllergan

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2009
Enrollment StartOct 1, 2009
Primary CompletionDec 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.6 years ago

Interventions

Ketorolac Tromethaminedrug

ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery

Bromfenacdrug

Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery

nepafenacdrug

drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery