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)

Phase 4

Completed

• Conditions: Post Operative Anterior Chamber Inflammation (Flare)
• Interventions: Drug: Bromfenac 0.09%; Drug: Ketorolac Tromethamine 0.45%

• Registration Number: NCT01023724
• Lead Sponsor: Bucci Laser Vision Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Primary Completion: 2010-01
• Study Completion: 2010-02
• Results First Submitted: 2011-05-25
• Status Verified: 2011-07
• Results First Submitted QC: 2011-07-28
• Last Update Submitted: 2011-07-28
• Results First Posted: 2011-08-26
• Last Update Posted: 2011-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bromfenac 0.09%	Bromfenac 0.09%	bromfenac 0.09% drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
Acuvail	Ketorolac Tromethamine 0.45%	Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.

Primary Outcome Measures

Name	Time	Method
Anterior Chamber Inflammation (Flare)	Day 14 of treatment	Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.

Trial Locations

Locations (1)

Bucci Laser Vision Institute; 🇺🇸 Wilkes-Barre, Pennsylvania, United States