Prolensa (Bromfenac) 0.07% QD vs. Ilevro (Nepafenac) 0.3%... | NCT01847638

NCT01847638

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Bausch & Lomb Incorporated	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prolensa (bromfenac 0.07%)	Active Comparator	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%)
Ilevro (nepafenac 0.3%)	Active Comparator	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%)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prolensa (bromfenac 0.07%)	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment of Inflammation Associated With 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=>	change from baseline to final at post op 42 days +/-7 days

Secondary Outcomes

Measure	Description	Time Frame
Visual Acuity	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 Outcomes

Measure	Description	Time Frame
Retinal Thickness	Change in Retinal Thickness from baseline to final postoperative visit as measured by an SD-OCT	change from baseline to final postoperative visit at 42 days +/- 7 days

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Melissa Toyos, MD	Toyos Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Toyos Clinic		Nashville	Tennessee	37203	United States

PubMed Identifier	Type	Citation	Retractions
30868419	Derived	Toyos MM. Comparison of Once-Daily Bromfenac 0.07% Versus Once-Daily Nepafenac 0.3% in Patients Undergoing Phacoemulsification. Ophthalmol Ther. 2019 Jun;8(2):261-270. doi: 10.1007/s40123-019-0174-x. Epub 2019 Mar 13.

Arm/Group Information

ID	Title	Description
FG000	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
FG001	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

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Treatment of Inflammation Associated With 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=>

patients undergoing uncomplicated cataract surgery

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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

ID	Term
D002386	Cataract
D010211	Papilledema
D007249	Inflammation

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D009901	Optic Nerve Diseases
D003389	Cranial Nerve Diseases

ID	Term
C053083	bromfenac
C414203	nepafenac