A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification

This study has been completed.

Sponsor:

Collaborator:

Allergan

Information provided by (Responsible Party):

Frank A. Bucci, Jr., M.D., Bucci Laser Vision Institute

ClinicalTrials.gov Identifier:

NCT01021761

First received: November 25, 2009

Last updated: August 26, 2011

Last verified: August 2011

History of Changes

Purpose

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	Intervention	Phase
Cataracts	Drug: Ketorolac Tromethamine Drug: Bromfenac Drug: nepafenac	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification

Resource links provided by NLM:

MedlinePlus related topics: Cataract

Drug Information available for: Tromethamine Dinoprostone Ketorolac Ketorolac tromethamine Nepafenac Bromfenac sodium Bromfenac

U.S. FDA Resources

Further study details as provided by Bucci Laser Vision Institute:

Primary Outcome Measures:

Aqueous PGE2 Inhibition [ Time Frame: Day 4 of treatment ] [ Designated as safety issue: No ]
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.


Enrollment:	126
Study Start Date:	October 2009
Study Completion Date:	January 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021761

Sponsors and Collaborators

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

Allergan

Investigators


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

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
Study First Received:	November 25, 2009
Results First Received:	May 25, 2011
Last Updated:	August 26, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Cataract Lens Diseases Eye Diseases Ketorolac Tromethamine Ketorolac 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

ClinicalTrials.gov processed this record on September 30, 2016

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