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

Phase 4

Completed

• Conditions: Cataracts
• Interventions: Drug: nepafenac 0.1%; Drug: Ketorolac Tromethamine 0.45%; Drug: bromfenac 0.09%

• Registration Number: NCT01001806
• 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 0.15 cc 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: 2009-10-23
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• 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: 2011-10-03

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.
• Subject 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 no previous eye surgery, with the exception of refractive surgery, but not within 6 months.
• No ocular use of prostaglandins within 2 weeks of surgery.
• Use of oral, injectable or topical ophthalmic steroids, nonsteroidal anti-inflammatory (NSAIDS) or immunosuppressants within 14 days prior to surgery.
• Contraindications to NSAIDS.
• Active ocular infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nevanac	nepafenac 0.1%	One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery
Acuvail	Ketorolac Tromethamine 0.45%	Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery
Xibrom	bromfenac 0.09%	Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery

Primary Outcome Measures

Name	Time	Method
Peak Aqueous Penetration	day 4 of treatment

Trial Locations

Locations (1)

Bucci Laser Vision Institute; 🇺🇸 Wilkes-Barre, Pennsylvania, United States