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

November 25, 2009
August 26, 2011
October 2009
December 2009   (final data collection date for primary outcome measure)
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.
Aqueous PGE2 levels [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01021761 on ClinicalTrials.gov Archive Site
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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
A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cataracts
  • 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
  • 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
  • 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: 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
    Intervention: Drug: Bromfenac
  • 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
    Intervention: Drug: nepafenac
  • 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.
    Intervention: Drug: Ketorolac Tromethamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
January 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01021761
2009 0199
No
Frank A. Bucci, Jr., M.D., Bucci Laser Vision Institute
Frank A. Bucci, Jr., M.D.
Allergan
Principal Investigator: Frank A Bucci, Jr., MD Bucci Laser Vision
Bucci Laser Vision Institute
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP