ClinicalTrials.Veeva

Menu

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)

B

Bucci Laser Vision Institute

Status and phase

Completed
Phase 4

Conditions

Post Operative Anterior Chamber Inflammation (Flare)

Treatments

Drug: Ketorolac Tromethamine 0.45%
Drug: Bromfenac 0.09%

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01023724
2009-11-06 1

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

bromfenac 0.09%
Active Comparator group
Description:
bromfenac 0.09% drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
Treatment:
Drug: Bromfenac 0.09%
Acuvail
Active Comparator group
Description:
Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
Treatment:
Drug: Ketorolac Tromethamine 0.45%

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems