A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)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 0.15cc 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; Drug: Bromfenac; Drug: nepafenac	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 Prostaglandin E2 (PGE2) Inhibition 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: Xibrom; Xibrom to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery	Drug: Bromfenac; Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery; Other Name: Xibrom
Active Comparator: Nevanac; Nevanac to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery	Drug: nepafenac; drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery; Other Name: Nevanac
Active Comparator: Acuvail; Acuvail to be given preoperatively. One drop 2 times (BID), 1 day pre op and day of surgery 3 doses prior to surgery.	Drug: Ketorolac Tromethamine; ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery; Other Name: Acuvail

Outcome Measures

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Primary Outcome Measures :

1. Aqueous PGE2 Inhibition [ Time Frame: Day 4 of treatment ]
   A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection.

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
• Subjects 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 o previous eye surgery with the exception of refractive surgery but not within 6 month
• No ocular use of prostaglandins within 2 weeks of surgery
• Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery
• Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
• Active ocular infection

Contacts and Locations

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Sponsors and Collaborators

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

Allergan

Investigators

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

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:	NCT01021761 History of Changes
Other Study ID Numbers:	2009 0199
First Posted:	November 30, 2009
Results First Posted:	August 26, 2011
Last Update Posted:	August 31, 2011
Last Verified:	August 2011

Additional relevant MeSH terms:

Cataract; Lens Diseases; Eye Diseases; Ketorolac; Ketorolac Tromethamine; Nepafenac; Bromfenac; Dinoprostone; 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; Oxytocics; Reproductive Control Agents