Back to resultsA Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)
Primary Purpose
Post Operative Anterior Chamber Inflammation (Flare)
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac Tromethamine 0.45%
Bromfenac 0.09%
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Anterior Chamber Inflammation (Flare)
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 intraocular 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 steroids,nonsteroidal anti-inflammatory drugs (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 Type
Active Comparator
Active Comparator
Arm Label
bromfenac 0.09%
Acuvail
Arm Description
bromfenac 0.09% drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
Outcomes
Primary Outcome Measures
Anterior Chamber Inflammation (Flare)
Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.
Secondary Outcome Measures
Full Information
NCT ID
NCT01023724
First Posted
December 1, 2009
Last Updated
July 28, 2011
Sponsor
Bucci Laser Vision Institute
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT01023724
Brief Title
A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)
Official Title
A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% BID and Bromfenac 0.09% BID
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bucci Laser Vision Institute
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Approximately 50 patients undergoing cataract surgery will be randomized in an even allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09% BID. Patients will be instructed to begin dosing study medication in the operative eye the day before surgery and continue dosing until day 14. KOWA flare measurements will be performed at postoperative day one and postoperative day 14. The amount of anterior chamber inflammation (flare) will be objectively measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Anterior Chamber Inflammation (Flare)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bromfenac 0.09%
Arm Type
Active Comparator
Arm Description
bromfenac 0.09% drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
Arm Title
Acuvail
Arm Type
Active Comparator
Arm Description
Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
Intervention Type
Drug
Intervention Name(s)
Ketorolac Tromethamine 0.45%
Intervention Description
Acuvail to be given 1 drop BID for one day prior to surgery and then 1 drop BID post operatively for 14 days.
Intervention Type
Drug
Intervention Name(s)
Bromfenac 0.09%
Intervention Description
Drug given one drop BID for one day pre operatively and then BID for 14 days post operatively
Primary Outcome Measure Information:
Title
Anterior Chamber Inflammation (Flare)
Description
Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.
Time Frame
Day 14 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 intraocular 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 steroids,nonsteroidal anti-inflammatory drugs (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 Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)
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