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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01847638
Recruitment Status : Completed
First Posted : May 7, 2013
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Melissa Toyos, Toyos Clinic

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%) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 1, 2013
Actual Primary Completion Date : July 16, 2016
Actual Study Completion Date : August 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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 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%




Primary Outcome Measures :
  1. Treatment of Inflammation Associated With Cataract Surgery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847638


Locations
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United States, Tennessee
Toyos Clinic
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Melissa Toyos
Bausch & Lomb Incorporated
Investigators
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Principal Investigator: Melissa Toyos, MD Toyos Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Melissa Toyos, Principal Investigator, Toyos Clinic
ClinicalTrials.gov Identifier: NCT01847638    
Other Study ID Numbers: MMT-2013
First Posted: May 7, 2013    Key Record Dates
Results First Posted: November 14, 2018
Last Update Posted: November 14, 2018
Last Verified: October 2018
Keywords provided by Melissa Toyos, Toyos Clinic:
Retinal edema
Cataract
inflammation
Additional relevant MeSH terms:
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Papilledema
Cataract
Inflammation
Pathologic Processes
Lens Diseases
Eye Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Nepafenac
Bromfenac
Ophthalmic Solutions
Pharmaceutical Solutions
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