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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

Page last updated: August 23, 2015

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