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)

July 28, 2011 updated by: Bucci Laser Vision Institute

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Wilkes-Barre, Pennsylvania, United States, 18702
        • Bucci Laser Vision Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: bromfenac 0.09%
bromfenac 0.09% drops to be given pre operatively for one day BID, and then postoperatively 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
Active Comparator: Acuvail
Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 14 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bucci Laser Vision Institute

Collaborators

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

August 26, 2011

Last Update Submitted That Met QC Criteria

July 28, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-11-06 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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