A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification

Sponsor
Frank A. Bucci, Jr., M.D. (Other)
Overall Status
Completed
CT.gov ID
NCT01001806
Collaborator
Allergan (Industry)
126
1
3
3
41.7

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 0.15 cc 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
  • Drug: Ketorolac Tromethamine 0.45%
  • Drug: bromfenac 0.09%
  • Drug: nepafenac 0.1%
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 Peak Aqueous Penetration 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: Acuvail

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

Drug: Ketorolac Tromethamine 0.45%
One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery
Other Names:
  • Acuvail
  • Active Comparator: Xibrom

    Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery

    Drug: bromfenac 0.09%
    One day pre operative 1 drop BID then 3 doses pre op day of surgery
    Other Names:
  • Xibrom
  • Active Comparator: Nevanac

    One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery

    Drug: nepafenac 0.1%
    One drop BID, 1 day pre operative and then 3 doses the day of surgery
    Other Names:
  • Nevanac
  • Outcome Measures

    Primary Outcome Measures

    1. Peak Aqueous Penetration [day 4 of treatment]

    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.

    • Subject 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 no previous eye surgery, with the exception of refractive surgery, but not within 6 months.

    • No ocular use of prostaglandins within 2 weeks of surgery.

    • Use of oral, injectable or topical ophthalmic steroids, nonsteroidal anti-inflammatory (NSAIDS) or immunosuppressants within 14 days prior to surgery.

    • Contraindications to NSAIDS.

    • Active ocular infection.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bucci Laser Vision Institute Wilkes-Barre Pennsylvania United States 18702

    Sponsors and Collaborators

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

    Investigators

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

    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:
    NCT01001806
    Other Study ID Numbers:
    • 2009-0199
    First Posted:
    Oct 27, 2009
    Last Update Posted:
    Oct 3, 2011
    Last Verified:
    Aug 1, 2011
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

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

    Baseline Characteristics

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

    Outcome Measures

    1. Primary Outcome
    Title Peak Aqueous Penetration
    Description
    Time Frame day 4 of treatment

    Outcome Measure Data

    Analysis Population Description
    Protocol specified enrollment of 126 subjects and analysis was performed per protocol.
    Arm/Group Title Acuvail Xibrom Nevanac
    Arm/Group Description Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery One day before surgery 1 drop BID, then 3 doses pre op day of surgery
    Measure Participants 42 42 42
    Mean (Standard Deviation) [ng/ml]
    688.87
    (749.6)
    67.64
    (62.4)
    447.1
    (225.7)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Acuvail Xibrom Nevanac
    Arm/Group Description Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery One day before surgery 1 drop BID, then 3 doses pre op day of surgery
    All Cause Mortality
    Acuvail Xibrom Nevanac
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Acuvail Xibrom Nevanac
    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
    Acuvail Xibrom Nevanac
    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:
    NCT01001806
    Other Study ID Numbers:
    • 2009-0199
    First Posted:
    Oct 27, 2009
    Last Update Posted:
    Oct 3, 2011
    Last Verified:
    Aug 1, 2011