Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1%

Sponsor
Toyos Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01310127
Collaborator
Bausch & Lomb Incorporated (Industry)
23
Enrollment
2
Arms
5.9
Duration (Months)

Study Details

Study Description

Brief Summary

This is a single-center, randomized, investigator-masked, parallel group, and active-comparator controlled study investigating the clinical outcomes for visual acuity and macular thickness after treatment with Bromday (bromfenac ophthalmic solution) 0.09% QD or Nevanac (nepafenac ophthalmic suspension) 0.1% TID in subjects who have undergone cataract extraction with posterior chamber intraocular lens implantation.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Detailed Description

Two topical NSAIDs currently approved for postoperative treatment of pain and inflammation in cataract surgery are bromfenac 0.09% and nepafenac 0.1%. Both purport to treat ocular inflammation by acting as a potent inhibitor of COX-1 and COX-2 enzymes. Clinical studies to date lack clarity on which topical NSAID may be the most efficacious.

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1% TID for Treatment of Ocular Inflammation Associated With Cataract Surgery
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
May 1, 2011

Arms and Interventions

ArmIntervention/Treatment
Experimental: Bromday

Patients receiving Bromday self-administered one drop of bromfenac 0.09% daily as a topical ophthalmic drop three days prior to cataract surgery, on the day of cataract surgery and 21 days post operatively.

Drug: Bromfenac
bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
Other Names:
  • Bromday (bromfenac ophthalmic solution) 0.9%
  • Active Comparator: Nevanac

    Patients in this arm self-administered nepafenac topical ophthalmic drops three times daily beginning 3 days prior to cataract surgery, on the day of surgery and for 21 days postoperatively in addition to usual cataract procedure.

    Drug: Nepafenac
    nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
    Other Names:
  • Nevanac (nepafenac ophthamic suspension) 0.1%
  • Outcome Measures

    Primary Outcome Measures

    1. Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities [Week 6]

      ETDRs visual acuities measured at week 6 following uncomplicated phacoemulsification (phaco). ETDRS charts are a standardized eye chart for visual acuity testing accepted by the National Eye Institute and the Food and Drug Administration. The scale is 30-90 letters with higher numbers signifying improved visual acuities.

    2. Summed Ocular Inflammation Score (SOIS) [Week 6]

      An assessment of the cells and flare, signs of inflammation in ocular tissue. SOIS (summed ocular inflammation) = cells in the anterior chamber/1mmx1mm high powered field+flare/1mmx1mm high powered field. The score of the number of cells in the anterior chamber per 1mmx1mm high powered field ranges from 0-4: 0=no cells, 1=1-5 cell, 2=6-15 cells, 3=16-30 cells, 4>=30 cells.Flare scores range from 0-3:(0=none, 1=mild, 2=moderate, 3=severe). Cell+flare are added together (cell score + flare score=SOIS score) for a SOIS score (minimum score=0 and maximal score of 7). Higher numbers would indicate more inflammation.The SOIS scale could range from 0-7 with 0 indicating no cells, no flare and 7 reflecting maximal cell 4(>30 cell/high powered field +3 (severe flare).

    3. OCT Retinal Thickness [Week 6]

      Stratus OCT scan retinal thickness/volume tabular output report. An experienced ophthalmic technician obtained two scan patterns. The first was the fast macular thickness using 6 radial line scans through a common central axis (fovea) with a retinal thickness/volume tabular output and a retinal-thickness output report. Central retinal thickness was defined as the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris in the central 1 mm area of the minimum 7 mm posterior pole scan. All scans were reviewed by the principal investigator for quality of foveal centration and signal strength. Macular volume is an objective indicator of macualr swelling and can illustrate the amount of inflammation following surgery. Only the study eye was assessed.

    4. Macular Volume [6 weeks]

      Stratus OCT by experienced technician. Reviewed by principal investigator for quality of foveal centration and signal strength

    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 are scheduled for unilateral cataract surgery (phacoemulsification or extracapsular) with posterior chamber intraocular lens implantation and for whom no other ophthalmic surgical procedures (e.g., relaxing incisions, iridectomy, conjunctival excisions, etc) are to be conducted 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.

    • If a woman capable of becoming pregnant, agree to have urine pregnancy testing performed at screening (must be negative) and agree to use a medically acceptable form of birth control throughout the study duration and for at least one week prior to and after completion of the study. Women considered capable of becoming pregnant include all females who have experienced menarche and who have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).

    • Have IOP ≥ 5 mmHg and ≤ 22 mmHg (in study eye) with or without anti glaucoma therapy at the pre operative screening visit (if >22 mmHg, adjust following pachymetry).

    Exclusion Criteria:
    • Have known hypersensitivity to bromfenac or Nepafenac or to 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 to other non steroidal anti inflammatory drugs (NSAIDs).

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

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

    • Have active corneal pathology noted in the study eye at the 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 the study eye is a criterion for exclusion.

    • 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.

    • Are pregnant or nursing/lactating.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Toyos Clinic
    • Bausch & Lomb Incorporated

    Investigators

    • Principal Investigator: Melissa Cable, MD, Discover Vision Centers

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Melissa Toyos, Principal Inevstigator, Toyos Clinic
    ClinicalTrials.gov Identifier:
    NCT01310127
    Other Study ID Numbers:
    • MAC-02-11
    First Posted:
    Mar 8, 2011
    Last Update Posted:
    Oct 28, 2020
    Last Verified:
    Oct 1, 2020
    Keywords provided by Melissa Toyos, Principal Inevstigator, Toyos Clinic
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsClinical outcomes of bromfenac ophthalmic solution 0.09% QD and nepafenac 0.1% ophthalmic suspension TID post cataract surgery with posterior chamber intraocular lens implantation, specifically looking at any differences in Early Treatment Diabetic Retinopathy Study visual acuities, macular volume, and/or retinal thickness changes.
    Pre-assignment DetailSubjects were randomized to receive bromfenac(n=12) QD or nepafenac(n=11) TID. Dosing was 3 days before cataract surgery through day 21 postop. Subjects could not have used ocular/topical, systemic NSAIDs, gentamicin, or cyclosporine ophthalmic emulsion 7 days or prostaglandins 30 days prior to initial dosing of test article or during the study.
    Arm/Group TitleBromdayNevanac
    Arm/Group DescriptionBromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgeryNepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
    Period Title: Overall Study
    STARTED1211
    COMPLETED1010
    NOT COMPLETED21

    Baseline Characteristics

    Arm/Group TitleBromdayNevanacTotal
    Arm/Group DescriptionBromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgeryNepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgeryTotal of all reporting groups
    Overall Participants121123
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    11
    91.7%
    10
    90.9%
    21
    91.3%
    >=65 years
    1
    8.3%
    1
    9.1%
    2
    8.7%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    70.1
    (10.5)
    69.7
    (9.0)
    69.9
    (9.5)
    Sex: Female, Male (Count of Participants)
    Female
    5
    41.7%
    6
    54.5%
    11
    47.8%
    Male
    7
    58.3%
    5
    45.5%
    12
    52.2%
    Region of Enrollment (participants) [Number]
    United States
    12
    100%
    11
    100%
    23
    100%

    Outcome Measures

    1. Primary Outcome
    TitleEarly Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities
    DescriptionETDRs visual acuities measured at week 6 following uncomplicated phacoemulsification (phaco). ETDRS charts are a standardized eye chart for visual acuity testing accepted by the National Eye Institute and the Food and Drug Administration. The scale is 30-90 letters with higher numbers signifying improved visual acuities.
    Time FrameWeek 6

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleBromdayNevanac
    Arm/Group DescriptionBromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgeryNepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
    Measure Participants1010
    Mean (Standard Deviation) [letters]
    51.3
    (6.818)
    52
    (6.750)
    2. Primary Outcome
    TitleSummed Ocular Inflammation Score (SOIS)
    DescriptionAn assessment of the cells and flare, signs of inflammation in ocular tissue. SOIS (summed ocular inflammation) = cells in the anterior chamber/1mmx1mm high powered field+flare/1mmx1mm high powered field. The score of the number of cells in the anterior chamber per 1mmx1mm high powered field ranges from 0-4: 0=no cells, 1=1-5 cell, 2=6-15 cells, 3=16-30 cells, 4>=30 cells.Flare scores range from 0-3:(0=none, 1=mild, 2=moderate, 3=severe). Cell+flare are added together (cell score + flare score=SOIS score) for a SOIS score (minimum score=0 and maximal score of 7). Higher numbers would indicate more inflammation.The SOIS scale could range from 0-7 with 0 indicating no cells, no flare and 7 reflecting maximal cell 4(>30 cell/high powered field +3 (severe flare).
    Time FrameWeek 6

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleBromdayNevanac
    Arm/Group DescriptionBromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgeryNepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
    Measure Participants1010
    Mean (Standard Deviation) [units on a scale]
    0.15
    (0.229)
    0.2
    (0.245)
    3. Primary Outcome
    TitleOCT Retinal Thickness
    DescriptionStratus OCT scan retinal thickness/volume tabular output report. An experienced ophthalmic technician obtained two scan patterns. The first was the fast macular thickness using 6 radial line scans through a common central axis (fovea) with a retinal thickness/volume tabular output and a retinal-thickness output report. Central retinal thickness was defined as the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris in the central 1 mm area of the minimum 7 mm posterior pole scan. All scans were reviewed by the principal investigator for quality of foveal centration and signal strength. Macular volume is an objective indicator of macualr swelling and can illustrate the amount of inflammation following surgery. Only the study eye was assessed.
    Time FrameWeek 6

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleBromdayNevanac
    Arm/Group DescriptionBromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgeryNepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
    Measure Participants1010
    Mean (Standard Deviation) [micrometers cubed]
    230.7
    (30.63)
    223.8
    (25.36)
    4. Primary Outcome
    TitleMacular Volume
    DescriptionStratus OCT by experienced technician. Reviewed by principal investigator for quality of foveal centration and signal strength
    Time Frame6 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleBromdayNevanac
    Arm/Group DescriptionBromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgeryNepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
    Measure Participants1010
    Mean (Standard Deviation) [mm cubed]
    0.1815
    (0.49)
    0.1765
    (0.34)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group TitleBromdayNevanac
    Arm/Group DescriptionBromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgeryNepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
    All Cause Mortality
    BromdayNevanac
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN)
    Serious Adverse Events
    BromdayNevanac
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/12 (0%) 0/11 (0%)
    Other (Not Including Serious) Adverse Events
    BromdayNevanac
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/12 (0%) 1/11 (9.1%)
    Eye disorders
    recurrent symptomatic postoperative iritis0/12 (0%) 01/11 (9.1%) 1

    Limitations/Caveats

    The major limitation in the study is that it was a small pilot study so that the direct correlations of the study variable could not be evaluated. There were ethnic differences in the groups that could also influence the data.

    More Information

    Certain Agreements

    All Principal Investigators ARE 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.

    Results Point of Contact

    Name/TitleMelissa Toyos, MD
    OrganizationDiscover Vision Centers
    Phone816-478-1230
    Emailmtoyos@discovervision.com
    Responsible Party:
    Melissa Toyos, Principal Inevstigator, Toyos Clinic
    ClinicalTrials.gov Identifier:
    NCT01310127
    Other Study ID Numbers:
    • MAC-02-11
    First Posted:
    Mar 8, 2011
    Last Update Posted:
    Oct 28, 2020
    Last Verified:
    Oct 1, 2020