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)

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=\>

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

change from baseline to final at post op 42 days +/-7 days

Results posted on

2018-11-14

Participant Flow

Participant milestones

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

Baseline characteristics by cohort
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	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=113 Participants	20 Participants n=163 Participants	32 Participants n=160 Participants
Age, Categorical >=65 years	13 Participants n=113 Participants	5 Participants n=163 Participants	18 Participants n=160 Participants
Age, Continuous	68.3 years n=113 Participants	66.9 years n=163 Participants	67.6 years n=160 Participants
Sex: Female, Male Female	17 Participants n=113 Participants	17 Participants n=163 Participants	34 Participants n=160 Participants
Sex: Female, Male Male	8 Participants n=113 Participants	8 Participants n=163 Participants	16 Participants n=160 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=113 Participants	1 Participants n=163 Participants	1 Participants n=160 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=113 Participants	24 Participants n=163 Participants	49 Participants n=160 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Black or African American	8 Participants n=113 Participants	7 Participants n=163 Participants	15 Participants n=160 Participants
Race (NIH/OMB) White	17 Participants n=113 Participants	18 Participants n=163 Participants	35 Participants n=160 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Region of Enrollment United States	25 Participants n=113 Participants	25 Participants n=163 Participants	50 Participants n=160 Participants

PRIMARY outcome

Timeframe: change from baseline to final at post op 42 days +/-7 days

Population: patients undergoing uncomplicated cataract surgery

Outcome measures

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 days

Population: 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

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 days

Population: 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

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%)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ilevro (Nepafenac 0.3%)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Melissa Toyos

Toyos Clinic

Phone: 6153274015

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place