Trial Outcomes & Findings for Prolensa (Bromfenac) 0.07% QD vs. Ilevro (Nepafenac) 0.3% QD for Treatment of Ocular Inflammation Post Cataract Surgery (NCT NCT01847638)
NCT ID: NCT01847638
Last Updated: 2018-11-14
Results Overview
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=\>
COMPLETED
NA
50 participants
change from baseline to final at post op 42 days +/-7 days
2018-11-14
Participant Flow
Participant milestones
| Measure |
Prolensa (Bromfenac 0.07%)
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
|
Ilevro (Nepafenac 0.3%)
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 Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prolensa (Bromfenac) 0.07% QD vs. Ilevro (Nepafenac) 0.3% QD for Treatment of Ocular Inflammation Post Cataract Surgery
Baseline characteristics by cohort
| Measure |
Total
n=50 Participants
Total of all reporting groups
|
Prolensa (Bromfenac 0.07%)
n=25 Participants
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
|
Ilevro (Nepafenac 0.3%)
n=25 Participants
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
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=35 Participants
|
12 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=35 Participants
|
13 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
|
Age, Continuous
|
67.6 years
n=35 Participants
|
68.3 years
n=39 Participants
|
66.9 years
n=41 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=35 Participants
|
17 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=35 Participants
|
8 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=35 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=35 Participants
|
25 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=35 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=35 Participants
|
8 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=35 Participants
|
17 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=35 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=35 Participants
|
25 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: change from baseline to final at post op 42 days +/-7 daysPopulation: patients undergoing uncomplicated cataract surgery
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=\>
Outcome measures
| Measure |
Prolensa (Bromfenac 0.07%)
n=25 Participants
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
|
Ilevro (Nepafenac 0.3%)
n=25 Participants
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
|
|---|---|---|
|
Treatment of Inflammation Associated With Cataract Surgery
|
0.01 units on a scale
Standard Deviation .3
|
0.01 units on a scale
Standard Deviation .4
|
SECONDARY outcome
Timeframe: baseline score to final postoperative visit at 42 days +/-7 daysPopulation: patients undergoing uncomplicated cataract surgery
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.
Outcome measures
| Measure |
Prolensa (Bromfenac 0.07%)
n=25 Participants
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
|
Ilevro (Nepafenac 0.3%)
n=25 Participants
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
|
|---|---|---|
|
Visual Acuity
|
.19 logMar
Standard Deviation .2
|
.21 logMar
Standard Deviation .25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: change from baseline to final postoperative visit at 42 days +/- 7 daysPopulation: Patients undergoing uncomplicated phacoemulsification with lens implantation at a single center by a single surgeon.
Change in Retinal Thickness from baseline to final postoperative visit as measured by an SD-OCT
Outcome measures
| Measure |
Prolensa (Bromfenac 0.07%)
n=25 Participants
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
|
Ilevro (Nepafenac 0.3%)
n=25 Participants
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
|
|---|---|---|
|
Retinal Thickness
|
276 microns
Standard Deviation 1.26
|
279 microns
Standard Deviation 2.1
|
Adverse Events
Prolensa (Bromfenac 0.07%)
Ilevro (Nepafenac 0.3%)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prolensa (Bromfenac 0.07%)
n=25 participants at risk
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
|
Ilevro (Nepafenac 0.3%)
n=25 participants at risk
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
|
|---|---|---|
|
Eye disorders
iritis
|
4.0%
1/25 • Number of events 1 • 2 years
|
0.00%
0/25 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place