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)
Information source: Bucci Laser Vision Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Operative Anterior Chamber Inflammation (Flare)
Intervention: Ketorolac Tromethamine 0.45% (Drug); Bromfenac 0.09% (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bucci Laser Vision Institute Official(s) and/or principal investigator(s): Frank A Bucci, Jr., MD, Principal Investigator, Affiliation: Bucci Laser Vision Institute
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.
Clinical Details
Official title: A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% BID and Bromfenac 0.09% BID
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Anterior Chamber Inflammation (Flare)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Bucci Laser Vision Institute, Wilkes-Barre, Pennsylvania 18702, United States
Additional Information
Starting date: December 2009
Last updated: July 28, 2011
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