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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Discover Vision Centers
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Melissa Toyos, MD, Discover Vision Centers
ClinicalTrials.gov Identifier:
NCT01847638
First received: April 16, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Cataract
Retinal Edema
Inflammation
Drug: Prolensa (bromfenac 0.07%)
Drug: Ilevro (nepafenac 0.3%)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Discover Vision Centers:

Primary Outcome Measures:
  • Treatment of inflammation associated with cataract surgery [ Time Frame: 42 days +/-7 days ] [ Designated as safety issue: No ]
    To investigate the clinical outcomes for inflammation after treatment with Prolensa (bromfenac ophthalmic solution) 0.07% QD in subjects who have undergone cataract extraction with posterior chamber intraocular lens implantation. 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.


Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: 42 days +/-7 days ] [ Designated as safety issue: No ]
    Change in ETDRS log MAR Visual Acuity


Other Outcome Measures:
  • Retinal Thickness [ Time Frame: 42 days +/- 7 days increase from baseline and prior data point will be measured at each visit ] [ Designated as safety issue: No ]
    Change in Retinal Thickness


Estimated Enrollment: 50
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: nepafenac ophthalmic suspension 0.3%

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847638

Contacts
Contact: Melissa Toyos, MD 6153274015 mtoyos@toyosclinic.com

Locations
United States, Tennessee
Toyos Clinic Recruiting
Nashville, Tennessee, United States, 37203
Contact: Melissa Toyos, MD    615-327-4015    mtoyos@toyosclinic.com   
Contact: Melissa Toyos, MD    6153274015    mtoyos@toyosclinic.com   
Principal Investigator: Melissa Toyos, MD         
Sponsors and Collaborators
Melissa Toyos, MD
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Melissa Toyos, MD Toyos Clinic
  More Information

No publications provided

Responsible Party: Melissa Toyos, MD, Principal Investigator, Discover Vision Centers
ClinicalTrials.gov Identifier: NCT01847638     History of Changes
Other Study ID Numbers: MMT-2013
Study First Received: April 16, 2013
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Discover Vision Centers:
Retinal edema
Cataract
inflammation

Additional relevant MeSH terms:
Edema
Inflammation
Cataract
Papilledema
Signs and Symptoms
Pathologic Processes
Lens Diseases
Eye Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Bromfenac
Nepafenac
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014