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)

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bucci Laser Vision Institute
• Collaborator: Allergan
• Treatments: Bromfenac; Ketorolac; Ketorolac Tromethamine

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