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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

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ClinicalTrials.gov Identifier: NCT01021761
Recruitment Status : Completed
First Posted : November 30, 2009
Results First Posted : August 26, 2011
Last Update Posted : August 31, 2011
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Frank A. Bucci, Jr., M.D., Bucci Laser Vision Institute

Study Description
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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 0.15cc 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 Drug: Bromfenac Drug: nepafenac Phase 4

Study Design
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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 Prostaglandin E2 (PGE2) Inhibition 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

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Aqueous PGE2 Inhibition [ Time Frame: Day 4 of treatment ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
  • 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
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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): NCT01021761


Sponsors and Collaborators
Frank A. Bucci, Jr., M.D.
Allergan
Investigators
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Principal Investigator: Frank A Bucci, Jr., MD Bucci Laser Vision
More Information
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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
First Posted: November 30, 2009    Key Record Dates
Results First Posted: August 26, 2011
Last Update Posted: August 31, 2011
Last Verified: August 2011
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Ketorolac
Ketorolac Tromethamine
Nepafenac
Bromfenac
Dinoprostone
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
Oxytocics
Reproductive Control Agents