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

Phase 4

Completed

• Conditions: Cataracts
• Interventions: Drug: Bromfenac; Drug: nepafenac; Drug: Ketorolac Tromethamine

• Registration Number: NCT01021761
• Lead Sponsor: Frank A. Bucci, Jr., M.D.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-11-27
• Study First Posted: 2009-11-30
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Results First Submitted: 2011-05-25
• Results First Submitted QC: 2011-07-28
• Status Verified: 2011-08
• Results First Posted: 2011-08-26
• Last Update Submitted: 2011-08-26
• Last Update Posted: 2011-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Subjects must be 18 years of age or older
• Scheduled for cataract surgery by phacoemulsification
• Subjects must be willing to comply with all study requirements and be willing to give informed consent

Exclusion Criteria

• Any subject that has a history of uveitis or active iritis
• Subject can have o previous eye surgery with the exception of refractive surgery but not within 6 month
• No ocular use of prostaglandins within 2 weeks of surgery
• Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery
• Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
• Active ocular infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xibrom	Bromfenac	Xibrom to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery
Nevanac	nepafenac	Nevanac to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery
Acuvail	Ketorolac Tromethamine	Acuvail to be given preoperatively. One drop 2 times (BID), 1 day pre op and day of surgery 3 doses prior to surgery.

Primary Outcome Measures

Name	Time	Method
Aqueous PGE2 Inhibition	Day 4 of treatment	A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection.