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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)

NCT01023724 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-08-26

Study results available
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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)

Interventions

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.

DRUG

Bromfenac 0.09%

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

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Bucci Laser Vision Institute

    lead OTHER

Principal Investigators

  • Frank A Bucci, Jr., MD · Bucci Laser Vision Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-01-31
Completion
2010-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01023724 on ClinicalTrials.gov