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)

Post Operative Anterior Chamber Inflammation (Flare) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023724
• Other study ID #: 2009-11-06 1
• Status: Completed
• Phase: Phase 4
• First received: December 1, 2009
• Last updated: July 28, 2011
• Start date: December 2009
• Est. completion date: February 2010

Study information

• Verified date: July 2011
• Source: Bucci Laser Vision Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Post Operative Anterior Chamber Inflammation (Flare)

Intervention

Drug:
• Ketorolac Tromethamine 0.45%
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 given one drop BID for one day pre operatively and then BID for 14 days post operatively

Locations

Country	Name	City	State
United States	Bucci Laser Vision Institute	Wilkes-Barre	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Bucci Laser Vision Institute	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior Chamber Inflammation (Flare)	Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.	Day 14 of treatment	No