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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
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
No text entered.

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.
No text entered.

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 
Overall Participants Analyzed 
[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 ]


  Serious Adverse Events


  Other Adverse Events


  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