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Prolensa (Bromfenac) 0.07% QD vs. Ilevro (Nepafenac) 0.3% QD for Treatment of Ocular Inflammation Post Cataract Surgery (QD)

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ClinicalTrials.gov Identifier: NCT01847638
Recruitment Status : Completed
First Posted : May 7, 2013
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Melissa Toyos, Toyos Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Cataract
Retinal Edema
Inflammation
Interventions Drug: Prolensa (bromfenac 0.07%)
Drug: Ilevro (nepafenac 0.3%)
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prolensa (Bromfenac 0.07%) Ilevro (Nepafenac 0.3%)
Hide Arm/Group Description

Subjects will instill one drop Prolensa (bromfenac 0.07%) into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.

Prolensa (bromfenac 0.07%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

Subjects will instill one drop into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.

Ilevro (nepafenac 0.3%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

Period Title: Overall Study
Started 25 25
Completed 25 25
Not Completed 0 0
Arm/Group Title Prolensa (Bromfenac 0.07%) Ilevro (Nepafenac 0.3%) Total
Hide Arm/Group Description

Subjects will instill one drop Prolensa (bromfenac 0.07%) into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.

Prolensa (bromfenac 0.07%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

Subjects will instill one drop into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.

Ilevro (nepafenac 0.3%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  48.0%
20
  80.0%
32
  64.0%
>=65 years
13
  52.0%
5
  20.0%
18
  36.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
68.3
(53 to 85)
66.9
(48 to 87)
67.6
(48 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
17
  68.0%
17
  68.0%
34
  68.0%
Male
8
  32.0%
8
  32.0%
16
  32.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Hispanic or Latino
0
   0.0%
1
   4.0%
1
   2.0%
Not Hispanic or Latino
25
 100.0%
24
  96.0%
49
  98.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  32.0%
7
  28.0%
15
  30.0%
White
17
  68.0%
18
  72.0%
35
  70.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25
 100.0%
25
 100.0%
50
 100.0%
1.Primary Outcome
Title Treatment of Inflammation Associated With Cataract Surgery
Hide Description Units on a scale. Biomicroscopy with slit lamp beam of 0.3 mm in width and 1.0 mm in height will be used to determine anterior cell and flare scores at each study visit by counting each individual white blood cell present and grading the flare (measure of protein and marker of inflammation in aqueous fluid). The sum of the severity of cell count and the flare grade will be called the Summed Ocular Inflammation Score (SOIS) and measured at each time point. The scale is 0-4 range for both values cells counted and flare where 0=no cell and 0=complete abscence of flare; 0.5 = 1-5 cells (trace) and 0= no flare; 1=6-15 cells and 1=very slight (barely detectable ) flare, 2=16-25 cells and 2=moderate flare (iris and lens clear), 3=26-30 cells and 3 =marked (iris and lens hazy) and 4=>
Time Frame change from baseline to final at post op 42 days +/-7 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients undergoing uncomplicated cataract surgery
Arm/Group Title Prolensa (Bromfenac 0.07%) Ilevro (Nepafenac 0.3%)
Hide Arm/Group Description:

Subjects will instill one drop Prolensa (bromfenac 0.07%) into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.

Prolensa (bromfenac 0.07%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

Subjects will instill one drop into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.

Ilevro (nepafenac 0.3%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.01  (.3) 0.01  (.4)
2.Secondary Outcome
Title Visual Acuity
Hide Description ETDRS log MAR Visual Acuity from baseline to final postoperative visit. The change was calculated as the difference of the value at the later time point minus the value at the earlier time point. The scale runs from -0.30 (corresponding to 20/10) or better visual acuity to 1(20/200) or worse visual acuity with the smaller or more negative numbers indicating better visual acuity outcomes and larger numbers indicating worsened visual acuity outcomes.
Time Frame baseline score to final postoperative visit at 42 days +/-7 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients undergoing uncomplicated cataract surgery
Arm/Group Title Prolensa (Bromfenac 0.07%) Ilevro (Nepafenac 0.3%)
Hide Arm/Group Description:

Subjects will instill one drop Prolensa (bromfenac 0.07%) into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.

Prolensa (bromfenac 0.07%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

Subjects will instill one drop into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.

Ilevro (nepafenac 0.3%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: logMar
.19  (.2) .21  (.25)
3.Other Pre-specified Outcome
Title Retinal Thickness
Hide Description Change in Retinal Thickness from baseline to final postoperative visit as measured by an SD-OCT
Time Frame change from baseline to final postoperative visit at 42 days +/- 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients undergoing uncomplicated phacoemulsification with lens implantation at a single center by a single surgeon.
Arm/Group Title Prolensa (Bromfenac 0.07%) Ilevro (Nepafenac 0.3%)
Hide Arm/Group Description:

Subjects will instill one drop Prolensa (bromfenac 0.07%) into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.

Prolensa (bromfenac 0.07%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

Subjects will instill one drop into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.

Ilevro (nepafenac 0.3%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: microns
276  (1.26) 279  (2.1)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prolensa (Bromfenac 0.07%) Ilevro (Nepafenac 0.3%)
Hide Arm/Group Description

Subjects will instill one drop Prolensa (bromfenac 0.07%) into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.

Prolensa (bromfenac 0.07%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

Subjects will instill one drop into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.

Ilevro (nepafenac 0.3%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

All-Cause Mortality
Prolensa (Bromfenac 0.07%) Ilevro (Nepafenac 0.3%)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/25 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Prolensa (Bromfenac 0.07%) Ilevro (Nepafenac 0.3%)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prolensa (Bromfenac 0.07%) Ilevro (Nepafenac 0.3%)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/25 (4.00%)      0/25 (0.00%)    
Eye disorders     
iritis  [1]  1/25 (4.00%)  1 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
iritis
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Melissa Toyos
Organization: Toyos Clinic
Phone: 6153274015
Responsible Party: Melissa Toyos, Toyos Clinic
ClinicalTrials.gov Identifier: NCT01847638     History of Changes
Other Study ID Numbers: MMT-2013
First Submitted: April 16, 2013
First Posted: May 7, 2013
Results First Submitted: January 5, 2018
Results First Posted: November 14, 2018
Last Update Posted: November 14, 2018