A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification

Sponsor
Frank A. Bucci, Jr., M.D. (Other)
Overall Status
Completed
CT.gov ID
NCT01021761
Collaborator
Allergan (Industry)
126
3
3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
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 :
Oct 1, 2009
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • Acuvail
  • Outcome Measures

    Primary Outcome Measures

    1. Aqueous PGE2 Inhibition [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Frank A. Bucci, Jr., M.D.
    • Allergan

    Investigators

    • Principal Investigator: Frank A Bucci, Jr., MD, Bucci Laser Vision

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Frank A. Bucci, Jr., M.D., Medical Director, Bucci Laser Vision Institute
    ClinicalTrials.gov Identifier:
    NCT01021761
    Other Study ID Numbers:
    • 2009 0199
    First Posted:
    Nov 30, 2009
    Last Update Posted:
    Aug 31, 2011
    Last Verified:
    Aug 1, 2011
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Xibrom Nevanac Acuvail
    Arm/Group Description Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
    Period Title: Overall Study
    STARTED 42 42 42
    COMPLETED 41 38 42
    NOT COMPLETED 1 4 0

    Baseline Characteristics

    Arm/Group Title Xibrom Nevanac Acuvail Total
    Arm/Group Description Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery. Total of all reporting groups
    Overall Participants 42 42 42 126
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    18
    42.9%
    15
    35.7%
    21
    50%
    54
    42.9%
    >=65 years
    24
    57.1%
    27
    64.3%
    21
    50%
    72
    57.1%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    72
    (31)
    74
    (29)
    75
    (30)
    74
    (29)
    Sex: Female, Male (Count of Participants)
    Female
    26
    61.9%
    29
    69%
    26
    61.9%
    81
    64.3%
    Male
    16
    38.1%
    13
    31%
    16
    38.1%
    45
    35.7%
    Region of Enrollment (participants) [Number]
    United States
    42
    100%
    42
    100%
    42
    100%
    126
    100%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Protocol specified 126 subjects to be enrolled and analysis was performed per protocol.
    Arm/Group Title Xibrom Nevanac Acuvail
    Arm/Group Description Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
    Measure Participants 42 42 42
    Mean (Standard Deviation) [pg/ml]
    288.7
    (226.05)
    320.4
    (205.6)
    224.8
    (164.87)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Xibrom Nevanac Acuvail
    Arm/Group Description Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
    All Cause Mortality
    Xibrom Nevanac Acuvail
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Xibrom Nevanac Acuvail
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/42 (0%) 0/42 (0%) 0/42 (0%)
    Other (Not Including Serious) Adverse Events
    Xibrom Nevanac Acuvail
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/42 (0%) 0/42 (0%) 0/42 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Frank A. Bucci, Jr., MD
    Organization Bucci Laser Vision
    Phone 570-825-5949
    Email Buccivision@aol.com
    Responsible Party:
    Frank A. Bucci, Jr., M.D., Medical Director, Bucci Laser Vision Institute
    ClinicalTrials.gov Identifier:
    NCT01021761
    Other Study ID Numbers:
    • 2009 0199
    First Posted:
    Nov 30, 2009
    Last Update Posted:
    Aug 31, 2011
    Last Verified:
    Aug 1, 2011