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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

Primary Purpose

Cataracts

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketorolac Tromethamine
Bromfenac
nepafenac
Sponsored by
Frank A. Bucci, Jr., M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Xibrom

    Nevanac

    Acuvail

    Arm Description

    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

    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

    Acuvail to be given preoperatively. One drop 2 times (BID), 1 day pre op and day of surgery 3 doses prior to surgery.

    Outcomes

    Primary Outcome Measures

    Aqueous PGE2 Inhibition
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 25, 2009
    Last Updated
    August 26, 2011
    Sponsor
    Frank A. Bucci, Jr., M.D.
    Collaborators
    Allergan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01021761
    Brief Title
    A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification
    Official Title
    A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    December 2009 (Actual)
    Study Completion Date
    January 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Frank A. Bucci, Jr., M.D.
    Collaborators
    Allergan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataracts

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    126 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Xibrom
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Nevanac
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Acuvail
    Arm Type
    Active Comparator
    Arm Description
    Acuvail to be given preoperatively. One drop 2 times (BID), 1 day pre op and day of surgery 3 doses prior to surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketorolac Tromethamine
    Other Intervention Name(s)
    Acuvail
    Intervention Description
    ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Bromfenac
    Other Intervention Name(s)
    Xibrom
    Intervention Description
    Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
    Intervention Type
    Drug
    Intervention Name(s)
    nepafenac
    Other Intervention Name(s)
    Nevanac
    Intervention Description
    drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
    Primary Outcome Measure Information:
    Title
    Aqueous PGE2 Inhibition
    Description
    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.
    Time Frame
    Day 4 of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frank A Bucci, Jr., MD
    Organizational Affiliation
    Bucci Laser Vision
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    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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