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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)

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ClinicalTrials.gov Identifier: NCT01023724
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : August 26, 2011
Last Update Posted : August 26, 2011
Sponsor:
Collaborator:
Allergan
Information provided by:
Bucci Laser Vision Institute

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.

Condition or disease Intervention/treatment Phase
Post Operative Anterior Chamber Inflammation (Flare) Drug: Ketorolac Tromethamine 0.45% Drug: Bromfenac 0.09% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% BID and Bromfenac 0.09% BID
Study Start Date : December 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : February 2010

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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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023724


Locations
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United States, Pennsylvania
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, United States, 18702
Sponsors and Collaborators
Bucci Laser Vision Institute
Allergan
Investigators
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Principal Investigator: Frank A Bucci, Jr., MD Bucci Laser Vision Institute

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Responsible Party: Frank A. Bucci, Jr., MD, Bucci Laser Vision
ClinicalTrials.gov Identifier: NCT01023724     History of Changes
Other Study ID Numbers: 2009-11-06 1
First Posted: December 2, 2009    Key Record Dates
Results First Posted: August 26, 2011
Last Update Posted: August 26, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Ketorolac
Ketorolac Tromethamine
Bromfenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action