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

Results First Received: May 25, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics/Dynamics Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Treatment
Condition:	Cataracts
Interventions:	Drug: Ketorolac Tromethamine Drug: Bromfenac Drug: nepafenac

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Xibrom	Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Nevanac	Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Acuvail	Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.

Participant Flow: Overall Study

	Xibrom	Nevanac	Acuvail
STARTED	42	42	42
COMPLETED	41	38	42
NOT COMPLETED	1	4	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Xibrom	Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Nevanac	Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Acuvail	Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
Total	Total of all reporting groups

Baseline Measures

	Xibrom	Nevanac	Acuvail	Total
Number of Participants [units: participants]	42	42	42	126
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	18	15	21	54
>=65 years	24	27	21	72
Age [units: years] Mean (Standard Deviation)	72 (31)	74 (29)	75 (30)	74 (29)
Gender [units: participants]
Female	26	29	26	81
Male	16	13	16	45
Region of Enrollment [units: participants]
United States	42	42	42	126

Outcome Measures

1. Primary:

Aqueous PGE2 Inhibition [ Time Frame: Day 4 of treatment ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Frank A. Bucci, Jr., MD
Organization: Bucci Laser Vision
phone: 570-825-5949
e-mail: Buccivision@aol.com

Responsible Party:	Frank A. Bucci, Jr., M.D., 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

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