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Trial record 6 of 25 for:    "Lens Disease" | "Nepafenac"

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

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ClinicalTrials.gov Identifier: NCT01021761
Recruitment Status : Completed
First Posted : November 30, 2009
Results First Posted : August 26, 2011
Last Update Posted : August 31, 2011
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Frank A. Bucci, Jr., M.D., Bucci Laser Vision Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Cataracts
Interventions Drug: Ketorolac Tromethamine
Drug: Bromfenac
Drug: nepafenac
Enrollment 126
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Xibrom Nevanac Acuvail
Hide Arm/Group Description Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
Period Title: Overall Study
Started 42 42 42
Completed 41 38 42
Not Completed 1 4 0
Arm/Group Title Xibrom Nevanac Acuvail Total
Hide Arm/Group Description Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery. Total of all reporting groups
Overall Number of Baseline Participants 42 42 42 126
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 42 participants 126 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
  42.9%
15
  35.7%
21
  50.0%
54
  42.9%
>=65 years
24
  57.1%
27
  64.3%
21
  50.0%
72
  57.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 42 participants 126 participants
72  (31) 74  (29) 75  (30) 74  (29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 42 participants 126 participants
Female
26
  61.9%
29
  69.0%
26
  61.9%
81
  64.3%
Male
16
  38.1%
13
  31.0%
16
  38.1%
45
  35.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 42 participants 42 participants 126 participants
42 42 42 126
1.Primary Outcome
Title Aqueous PGE2 Inhibition
Hide Description 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.
Time Frame Day 4 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol specified 126 subjects to be enrolled and analysis was performed per protocol.
Arm/Group Title Xibrom Nevanac Acuvail
Hide Arm/Group Description:
Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
Overall Number of Participants Analyzed 42 42 42
Mean (Standard Deviation)
Unit of Measure: pg/ml
288.7  (226.05) 320.4  (205.6) 224.8  (164.87)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Xibrom Nevanac Acuvail
Hide Arm/Group Description Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
All-Cause Mortality
Xibrom Nevanac Acuvail
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Xibrom Nevanac Acuvail
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/42 (0.00%)   0/42 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Xibrom Nevanac Acuvail
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/42 (0.00%)   0/42 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Frank A. Bucci, Jr., MD
Organization: Bucci Laser Vision
Phone: 570-825-5949
EMail: Buccivision@aol.com
Layout table for additonal information
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
First Submitted: November 25, 2009
First Posted: November 30, 2009
Results First Submitted: May 25, 2011
Results First Posted: August 26, 2011
Last Update Posted: August 31, 2011