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

• Sponsor: Melissa Toyos (Other)
• Overall Status: Completed
• CT.gov ID: NCT01847638
• Collaborator: Bausch & Lomb Incorporated (Industry)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 64.7
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

To investigate inflammation, visual acuity and macular thickness after treatment with Prolensa vs Ilevro after cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Cataract; Retinal Edema; Inflammation	Drug: Prolensa (bromfenac 0.07%); Drug: Ilevro (nepafenac 0.3%)	N/A

Detailed Description

To investigate the clinical outcomes for inflammation, visual acuity and macular thickness after treatment with Prolensa (bromfenac ophthalmic solution) 0.07% QD in subjects who have undergone cataract extraction with posterior chamber intraocular lens implantation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Outcomes 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
• Actual Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jul 16, 2016
• Actual Study Completion Date: Aug 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: 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; Other Names: bromfenac ophthalmic solution 0.07%
Active Comparator: 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.	Drug: 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; Other Names: nepafenac ophthalmic suspension 0.3%

Outcome Measures

Primary Outcome Measures

1. Treatment of Inflammation Associated With Cataract Surgery [change from baseline to final at post op 42 days +/-7 days]

   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=>

Secondary Outcome Measures

1. Visual Acuity [baseline score to final postoperative visit at 42 days +/-7 days]

   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.

Other Outcome Measures

1. Retinal Thickness [change from baseline to final postoperative visit at 42 days +/- 7 days]

   Change in Retinal Thickness from baseline to final postoperative visit as measured by an SD-OCT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Are male or female at least 18 years of age who require cataract surgery and no other surgical procedures during the cataract surgery.

• Agree not to have any other ocular surgical procedures in the study or fellow (non study) eye within 15 days prior to the initiation of dosing with the test article or throughout the duration of the study.

• Have a Best Corrected Visual Acuity of 20/200 or better in either eye.

• Are able to self administer test article (or have a caregiver available to instill all doses of test article).

Exclusion Criteria:

• Have known hypersensitivity to bromfenac, nepafenac, loteprednol or any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).

• Have a known hypersensitivity to salicylates (i.e., aspirin) or NSAIDs (nonsteroidal antiinflammatory drug).

• Have intraocular inflammation (i.e., cells or flare in the anterior chamber as measured on slit lamp examination) in study eye at screening visit.

• Have a known blood dyscrasia or bone marrow suppression, a diagnosis of uncontrolled/unstable peptic ulcer disease, inflammatory bowel disease, or ulcerative colitis, or any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune, hepatic, renal, or central nervous system disease.

• Have used ocular, topical, or systemic NSAIDs or ocular, topical, or systemic gentamicin, or cyclosporine ophthalmic emulsion within 7 days prior to initiation of dosing with the test article or throughout the duration of study,with exception of allowing patients on a stable dose of aspirin 81 mg daily or less.

• Have used ocular prostaglandins within 30 days prior to initiation of dosing with test article or throughout the duration of study.

• Have active corneal pathology noted in the study eye at screening visit. Active corneal pathology is defined as corneal pathology that is non stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment. Superficial punctate keratitis in study eye.

• Have any extraocular/intraocular inflammation in the study eye at screening visit (blepharitis allowed if mild only, and no concurrent conjunctivitis or lid erythema/edema) or ongoing, unresolved uveitis.

• Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening.

• Have had radial keratotomy, corneal transplant, or corneal refractive surgery in the study eye within the last two years.

• Have a history of abuse of alcohol/drugs within six months prior to the screening visit.

• Are pregnant or nursing/lactating.

• Have participated in any other study of an investigational drug or device within 30 days prior to randomization.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toyos Clinic	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• Melissa Toyos
• Bausch & Lomb Incorporated

Investigators

• Principal Investigator: Melissa Toyos, MD, Toyos Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Melissa Toyos, Principal Investigator, Toyos Clinic
• ClinicalTrials.gov Identifier: NCT01847638
• Other Study ID Numbers: MMT-2013
• First Posted: May 7, 2013
• Last Update Posted: Nov 14, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by Melissa Toyos, Principal Investigator, Toyos Clinic: Retinal edema; Cataract; inflammation
• Additional relevant MeSH terms: Papilledema; Cataract; Inflammation; Nepafenac; Bromfenac; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Prolensa (Bromfenac 0.07%)	Ilevro (Nepafenac 0.3%)
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

Baseline Characteristics

Arm/Group Title	Prolensa (Bromfenac 0.07%)	Ilevro (Nepafenac 0.3%)	Total
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 Participants	25	25	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 48%	20 80%	32 64%
>=65 years	13 52%	5 20%	18 36%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	68.3	66.9	67.6
Sex: Female, Male (Count of Participants)
Female	17 68%	17 68%	34 68%
Male	8 32%	8 32%	16 32%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 4%	1 2%
Not Hispanic or Latino	25 100%	24 96%	49 98%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	8 32%	7 28%	15 30%
White	17 68%	18 72%	35 70%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	25 100%	25 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Treatment of Inflammation Associated With Cataract Surgery
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

Outcome Measure Data

Analysis Population Description

patients undergoing uncomplicated cataract surgery

Arm/Group Title	Prolensa (Bromfenac 0.07%)	Ilevro (Nepafenac 0.3%)
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
Measure Participants	25	25
Mean (Standard Deviation) [units on a scale]	0.01 (.3)	0.01 (.4)

2. Secondary Outcome

Title	Visual Acuity
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

Outcome Measure Data

Analysis Population Description

patients undergoing uncomplicated cataract surgery

Arm/Group Title	Prolensa (Bromfenac 0.07%)	Ilevro (Nepafenac 0.3%)
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
Measure Participants	25	25
Mean (Standard Deviation) [logMar]	.19 (.2)	.21 (.25)

3. Other Pre-specified Outcome

Title	Retinal Thickness
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

Outcome Measure Data

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%)
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
Measure Participants	25	25
Mean (Standard Deviation) [microns]	276 (1.26)	279 (2.1)

Adverse Events

Time Frame	2 years
Arm/Group Title	Prolensa (Bromfenac 0.07%)		Ilevro (Nepafenac 0.3%)
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Prolensa (Bromfenac 0.07%)		Ilevro (Nepafenac 0.3%)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Prolensa (Bromfenac 0.07%)		Ilevro (Nepafenac 0.3%)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/25 (4%)		0/25 (0%)
Eye disorders
iritis	1/25 (4%)	1	0/25 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

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.