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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Frank A. Bucci, Jr., M.D., Bucci Laser Vision Institute
ClinicalTrials.gov Identifier:
NCT01001806
First received: October 23, 2009
Last updated: August 26, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Cataracts
Drug: Ketorolac Tromethamine 0.45%
Drug: bromfenac 0.09%
Drug: nepafenac 0.1%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Peak Aqueous Penetration of Acuvail, Xibrom, and Nevanac in Patients Undergoing Phacoemulsification

Resource links provided by NLM:


Further study details as provided by Bucci Laser Vision Institute:

Primary Outcome Measures:
  • Peak Aqueous Penetration [ Time Frame: day 4 of treatment ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Nevanac

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001806

Locations
United States, Pennsylvania
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, United States, 18702
Sponsors and Collaborators
Frank A. Bucci, Jr., M.D.
Allergan
Investigators
Principal Investigator: Frank A Bucci, Jr.,, MD Bucci Laser Vision Institute
  More Information

No publications provided

Responsible Party: Frank A. Bucci, Jr., M.D., Medical Director, Bucci Laser Vision Institute
ClinicalTrials.gov Identifier: NCT01001806     History of Changes
Other Study ID Numbers: 2009-0199
Study First Received: October 23, 2009
Results First Received: May 25, 2011
Last Updated: August 26, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bromfenac
Ketorolac
Ketorolac Tromethamine
Nepafenac
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014