ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01001806
Recruitment Status : Completed
First Posted : October 27, 2009
Results First Posted : August 26, 2011
Last Update Posted : October 3, 2011
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Frank A. Bucci, Jr., M.D., Bucci Laser Vision Institute

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.

Condition or disease Intervention/treatment Phase
Cataracts Drug: Ketorolac Tromethamine 0.45% Drug: bromfenac 0.09% Drug: nepafenac 0.1% Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
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
Study Start Date : October 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

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 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



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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.

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

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 Posted: October 27, 2009    Key Record Dates
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