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A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)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:
NCT01021761
First received: November 25, 2009
Last updated: August 26, 2011
Last verified: August 2011
History of Changes
  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 0.15cc 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
Drug: Bromfenac
Drug: nepafenac
 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 Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Bucci Laser Vision Institute:

Primary Outcome Measures:
  • Aqueous PGE2 Inhibition [ Time Frame: Day 4 of treatment ] [ Designated as safety issue: No ]
    A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection.


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: Xibrom
Xibrom to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery
 Drug: Bromfenac
Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Other Name: Xibrom
Active Comparator: Nevanac
Nevanac to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery
 Drug: nepafenac
drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Other Name: Nevanac
Active Comparator: Acuvail
Acuvail to be given preoperatively. One drop 2 times (BID), 1 day pre op and day of surgery 3 doses prior to surgery.
 Drug: Ketorolac Tromethamine
ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Other Name: Acuvail

  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
  • Subjects 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 o previous eye surgery with the exception of refractive surgery but not within 6 month
  • No ocular use of prostaglandins within 2 weeks of surgery
  • Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery
  • Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Active ocular infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021761

Sponsors and Collaborators
Frank A. Bucci, Jr., M.D.
Allergan
Investigators
Principal Investigator: Frank A Bucci, Jr., MD Bucci Laser Vision
  More Information

No publications provided

Responsible Party: Frank A. Bucci, Jr., M.D., Medical Director, Bucci Laser Vision Institute
ClinicalTrials.gov Identifier: NCT01021761     History of Changes
Other Study ID Numbers: 2009 0199
Study First Received: November 25, 2009
Results First Received: May 25, 2011
Last Updated: August 26, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013