Back to resultsA Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification
Primary Purpose
Cataracts
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac Tromethamine 0.45%
bromfenac 0.09%
nepafenac 0.1%
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts
Eligibility Criteria
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.
Sites / Locations
- Bucci Laser Vision Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Acuvail
Xibrom
Nevanac
Arm Description
Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery
Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery
One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery
Outcomes
Primary Outcome Measures
Peak Aqueous Penetration
Secondary Outcome Measures
Full Information
NCT ID
NCT01001806
First Posted
October 23, 2009
Last Updated
August 26, 2011
Sponsor
Frank A. Bucci, Jr., M.D.
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT01001806
Brief Title
A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification
Official Title
A Comparison of Peak Aqueous Penetration 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 0.15 cc 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
Acuvail
Arm Type
Active Comparator
Arm Description
Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery
Arm Title
Xibrom
Arm Type
Active Comparator
Arm Description
Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery
Arm Title
Nevanac
Arm Type
Active Comparator
Arm Description
One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery
Intervention Type
Drug
Intervention Name(s)
Ketorolac Tromethamine 0.45%
Other Intervention Name(s)
Acuvail
Intervention Description
One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery
Intervention Type
Drug
Intervention Name(s)
bromfenac 0.09%
Other Intervention Name(s)
Xibrom
Intervention Description
One day pre operative 1 drop BID then 3 doses pre op day of surgery
Intervention Type
Drug
Intervention Name(s)
nepafenac 0.1%
Other Intervention Name(s)
Nevanac
Intervention Description
One drop BID, 1 day pre operative and then 3 doses the day of surgery
Primary Outcome Measure Information:
Title
Peak Aqueous Penetration
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank A Bucci, Jr.,, MD
Organizational Affiliation
Bucci Laser Vision Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bucci Laser Vision Institute
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification
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