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

A Comparison of Peak Aqueous Penetration of Acuvail, Xibrom, and Nevanac in Patients Undergoing Phacoemulsification

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 Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Drug: Ketorolac Tromethamine 0.45%; Drug: bromfenac 0.09%; Drug: nepafenac 0.1%

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States, 18702
      • Bucci Laser Vision Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acuvail; Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery	Drug: Ketorolac Tromethamine 0.45%; One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery; Other Names: Acuvail
Active Comparator: Xibrom; Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery	Drug: bromfenac 0.09%; One day pre operative 1 drop BID then 3 doses pre op day of surgery; Other Names: Xibrom
Active Comparator: Nevanac; One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery	Drug: nepafenac 0.1%; One drop BID, 1 day pre operative and then 3 doses the day of surgery; Other Names: Nevanac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak Aqueous Penetration	day 4 of treatment

Collaborators and Investigators

• Sponsor: Frank A. Bucci, Jr., M.D.
• Collaborators: Allergan
• Investigators: Principal Investigator: Frank A Bucci, Jr.,, MD, Bucci Laser Vision Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: October 23, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (Estimate): October 27, 2009

Study Record Updates

• Last Update Posted (Estimate): October 3, 2011
• Last Update Submitted That Met QC Criteria: August 26, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Bromfenac; Ketorolac Tromethamine; Nepafenac
• Other Study ID Numbers: 2009-0199