Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03417557
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
2.7
Actual Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Comfilcon A lens (test)
  • Device: Omafilcon B lens (control)
N/A

Detailed Description

This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses
Actual Study Start Date :
Jan 12, 2018
Actual Primary Completion Date :
Apr 3, 2018
Actual Study Completion Date :
Apr 3, 2018

Arms and Interventions

ArmIntervention/Treatment
Experimental: Comfilcon A lens (test)

Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study.

Device: Comfilcon A lens (test)
contact lens
Other Names:
  • Biofinity multifocal toric Lens (test)
  • Active Comparator: Omafilcon B Lens (control)

    Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study.

    Device: Omafilcon B lens (control)
    contact lens
    Other Names:
  • Proclear multifocal toric lens (control)
  • Outcome Measures

    Primary Outcome Measures

    1. Visual Acuity [up to 3 hours]

      Visual acuity is assessed for test and control lens on a logMAR chart

    Secondary Outcome Measures

    1. Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity [up to 3 hours]

      Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.

    2. Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity [up to 3 hours]

      Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.

    3. Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity [up to 3 hours]

      Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Has had a self-reported oculo-visual examination in the last two years.

    • Is between ages 40-75 years, inclusive and has full legal capacity to volunteer.

    • Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule.

    • Is able to participate in Parts A and B related to this work.

    • Has a contact lens spherical prescription between +10.00 to 10.00D (inclusive).

    • Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).

    • Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.

    • Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected.

    • Currently wears soft contact lenses.

    • Has clear corneas and no active ocular disease.

    • Has not worn lenses for at least 12 hours before the examination.

    Exclusion Criteria:
    A person will be excluded from the study if he/she:
    • Has never worn contact lenses before.

    • Has any systemic disease affecting ocular health.

    • Is using any systemic or topical medications that will affect ocular health.

    • Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.

    • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.

    • Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.

    • Is aphakic.

    • Has undergone corneal refractive surgery.

    • Is participating in any other type of eye related clinical or research study.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana UniversityBloomingtonIndianaUnited States47405

    Sponsors and Collaborators

    • Coopervision, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT03417557
    Other Study ID Numbers:
    • CV-18-10
    First Posted:
    Jan 31, 2018
    Last Update Posted:
    May 4, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment DetailThree subjects did not meet the inclusion criteria. Seventeen (17) subjects completed all visits and were included in the analysis.
    Arm/Group TitleComfilcon A Lens Then Omafilcon B LensOmafilcon B Lens Then Comfilcon A
    Arm/Group DescriptionSubjects are randomized to wear comfilcon A lens for up to 3 hours then omafilcon B lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lensSubjects are randomized to wear omafilcon B lens for up to 3 hours then comfilcon A lens up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens
    Period Title: 1st Intervention (3 Hours)
    STARTED89
    COMPLETED89
    NOT COMPLETED00
    Period Title: 1st Intervention (3 Hours)
    STARTED98
    COMPLETED98
    NOT COMPLETED00

    Baseline Characteristics

    Arm/Group TitleComfilcon A Lens (Test) and Omafilcon B (Control)
    Arm/Group DescriptionSubjects were randomized to wear the comfilcon A (test) or omafilcon B (control) lens for up to 3 hours, either as first or second lens during this cross over study.
    Overall Participants17
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    54
    (7)
    Sex: Female, Male (Count of Participants)
    Female
    11
    64.7%
    Male
    6
    35.3%
    Race and Ethnicity Not Collected (Count of Participants)
    Region of Enrollment (participants) [Number]
    United States
    17
    100%

    Outcome Measures

    1. Primary Outcome
    TitleVisual Acuity
    DescriptionVisual acuity is assessed for test and control lens on a logMAR chart
    Time Frameup to 3 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleComfilcon A Lens (Test)Omafilcon B Lens (Control)
    Arm/Group DescriptionSubjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lensSubjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens
    Measure Participants1717
    Distance: Binocular
    -0.01
    (0.09)
    -0.03
    (0.16)
    Distance: Monocular (dominate eye)
    -0.05
    (0.12)
    0.06
    (0.21)
    Distant: Monocular (non-dominate eye)
    0.02
    (0.13)
    0.13
    (0.22)
    Near: Binocular
    0.05
    (0.09)
    0.03
    (0.07)
    Near: Monocular (dominate eye)
    0.14
    (0.11)
    0.17
    (0.13)
    Near: Monocular (non-dominate eye)
    0.10
    (0.13)
    0.04
    (0.18)
    2. Secondary Outcome
    TitleSubjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity
    DescriptionSubjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
    Time Frameup to 3 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleComfilcon A Lens (Test)Omafilcon B Lens (Control)
    Arm/Group DescriptionSubjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lensSubjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens
    Measure Participants1717
    Mean (Standard Deviation) [units on a scale]
    91
    (8)
    79
    (24)
    3. Secondary Outcome
    TitleSubjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity
    DescriptionSubjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
    Time Frameup to 3 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleComfilcon A Lens (Test)Omafilcon B Lens (Control)
    Arm/Group DescriptionSubjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lensSubjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens
    Measure Participants1717
    Mean (Standard Deviation) [units on a scale]
    87
    (12)
    82
    (17)
    4. Secondary Outcome
    TitleSubjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity
    DescriptionSubjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
    Time Frameup to 3 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleComfilcon A Lens (Test)Omafilcon B Lens (Control)
    Arm/Group DescriptionSubjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lensSubjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens
    Measure Participants1717
    Mean (Standard Deviation) [units on a scale]
    84
    (17)
    79
    (26)

    Adverse Events

    Time FrameUp to 3 hours per intervention.
    Adverse Event Reporting Description
    Arm/Group TitleComfilcon A Lens (Test)Omafilcon B Lens (Control)
    Arm/Group DescriptionSubjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study. Comfilcon A lens (test): contact lensSubjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study. Omafilcon B lens (control): contact lens
    All Cause Mortality
    Comfilcon A Lens (Test)Omafilcon B Lens (Control)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/17 (0%) 0/17 (0%)
    Serious Adverse Events
    Comfilcon A Lens (Test)Omafilcon B Lens (Control)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/17 (0%) 0/17 (0%)
    Other (Not Including Serious) Adverse Events
    Comfilcon A Lens (Test)Omafilcon B Lens (Control)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/17 (0%) 0/17 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There IS 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/TitleMyhanh Nguyen, Sr. Optometrist
    OrganizationCooperVision
    Phone19257306716
    EmailMNguyen@coopervision.com
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT03417557
    Other Study ID Numbers:
    • CV-18-10
    First Posted:
    Jan 31, 2018
    Last Update Posted:
    May 4, 2020
    Last Verified:
    Apr 1, 2020