A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification

Study Description

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Brief Summary:

Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.

Condition or disease	Intervention/treatment	Phase
Cataracts	Drug: Ketorolac Tromethamine 0.45%; Drug: bromfenac 0.09%; Drug: nepafenac 0.1%	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	126 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Comparison of Peak Aqueous Penetration of Acuvail, Xibrom, and Nevanac in Patients Undergoing Phacoemulsification
Study Start Date :	October 2009
Actual Primary Completion Date :	December 2009
Actual Study Completion Date :	January 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Acuvail; Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery	Drug: Ketorolac Tromethamine 0.45%; One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery; Other Name: Acuvail
Active Comparator: Xibrom; Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery	Drug: bromfenac 0.09%; One day pre operative 1 drop BID then 3 doses pre op day of surgery; Other Name: Xibrom
Active Comparator: Nevanac; One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery	Drug: nepafenac 0.1%; One drop BID, 1 day pre operative and then 3 doses the day of surgery; Other Name: Nevanac

Outcome Measures

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Primary Outcome Measures :

1. Peak Aqueous Penetration [ Time Frame: day 4 of treatment ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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 eye 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 ophthalmic steroids, nonsteroidal anti-inflammatory (NSAIDS) or immunosuppressants within 14 days prior to surgery.
• Contraindications to NSAIDS.
• Active ocular infection.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Frank A. Bucci, Jr., M.D.

Allergan

Investigators

Principal Investigator:	Frank A Bucci, Jr.,, MD	Bucci Laser Vision Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Frank A. Bucci, Jr., M.D., Medical Director, Bucci Laser Vision Institute
ClinicalTrials.gov Identifier:	NCT01001806 History of Changes
Other Study ID Numbers:	2009-0199
First Posted:	October 27, 2009
Results First Posted:	August 26, 2011
Last Update Posted:	October 3, 2011
Last Verified:	August 2011

Additional relevant MeSH terms:

Cataract; Lens Diseases; Eye Diseases; Ketorolac; Ketorolac Tromethamine; Nepafenac; 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