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)

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.

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Key information

Conditions

Post Operative Anterior Chamber Inflammation (Flare)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac Tromethamine 0.45%

Drug

Acuvail to be given 1 drop BID for one day prior to surgery and then 1 drop BID post operatively for 14 days.

bromfenac 0.09%

Drug

Drug given one drop BID for one day pre operatively and then BID for 14 days post operatively

Primary outcomes

Anterior Chamber Inflammation (Flare)

Time frame: Day 14 of treatment

Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.

Sponsors and collaborators

Lead sponsor

Bucci Laser Vision Institute

Other

Collaborators

Allergan

Registry information

Official study title

A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% BID and Bromfenac 0.09% BID

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Dec 2, 2009
Registry last updated: Aug 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.