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)

NCT01023724 | Completed Phase 4 Results

• 1 other identifier: 2009-11-06 1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Anterior Chamber Inflammation (Flare)

Outcome Measures

Primary Outcomes (1)

• Anterior Chamber Inflammation (Flare)

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

  Day 14 of treatment

Study Arms (2)

bromfenac 0.09%

ACTIVE COMPARATOR

bromfenac 0.09% drops to be given pre operatively for one day BID, and then postoperatively for 14 days.

Drug: Bromfenac 0.09%

Acuvail

ACTIVE COMPARATOR

Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.

Drug: Ketorolac Tromethamine 0.45%

Interventions

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.

Acuvail

Bromfenac 0.09% DRUG

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

bromfenac 0.09%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bucci Laser Vision Institute: lead
• Allergan: collaborator

Study Sites (1)

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

Location

Results Point of Contact

• Title: Frank A. Bucci, Jr., MD
• Organization: Bucci Laser Visiosn

Buccivision@aol.com

570-825-5949

Study Officials

• Frank A Bucci, Jr., MD

  Bucci Laser Vision Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: August 26, 2011
• Results First Posted: August 26, 2011

Record last verified: 2011-07

Locations

US (1)