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

NCT01847638 | Completed Results

• 1 other identifier: MMT-2013
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract; Retinal Edema; Inflammation

Keywords

Retinal edema; Cataract; inflammation

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Visual Acuity

  baseline score to final postoperative visit at 42 days +/-7 days

Other Outcomes (1)

• Retinal Thickness

  change from baseline to final postoperative visit at 42 days +/- 7 days

Study Arms (2)

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

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

Also known as: bromfenac ophthalmic solution 0.07%

Prolensa (bromfenac 0.07%)

Ilevro (nepafenac 0.3%) 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

Also known as: nepafenac ophthalmic suspension 0.3%

Ilevro (nepafenac 0.3%)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Melissa Toyos: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

Toyos Clinic

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• 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.

  PMID: 30868419 DERIVED

MeSH Terms

Conditions

Cataract; Papilledema; Inflammation

Interventions

bromfenac; nepafenac

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Melissa Toyos
• Organization: Toyos Clinic

mtoyos@toyosclinic.com

6153274015

Study Officials

• Melissa Toyos, MD

  Toyos Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: May 7, 2013
• Study Start: April 1, 2013
• Primary Completion: July 16, 2016
• Study Completion: August 23, 2018
• Last Updated: November 14, 2018
• Results First Posted: November 14, 2018

Record last verified: 2018-10

Locations

US (1)