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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:
ClinicalTrials.gov Identifier:
NCT01001806
First Posted: October 27, 2009
Last Update Posted: October 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
Frank A. Bucci, Jr., M.D., Bucci Laser Vision Institute
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Frank A. Bucci, Jr., M.D., Bucci Laser Vision Institute:

Primary Outcome Measures:
  • Peak Aqueous Penetration [ Time Frame: day 4 of treatment ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 23, 2009
First Posted: October 27, 2009
Results First Submitted: May 25, 2011
Results First Posted: August 26, 2011
Last Update Posted: October 3, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Ketorolac
Ketorolac Tromethamine
Nepafenac
Bromfenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action