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Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04404725
Collaborator
(none)
64
Enrollment
7
Locations
2
Arms
11.7
Actual Duration (Months)
9.1
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism.

Condition or Disease Intervention/Treatment Phase
  • Device: comfilcon A
  • Device: Samfilcon A
 N/A

Detailed Description

The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism. This is a prospective, randomized, participant masked, crossover, bilateral dispensing study.

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism
Actual Study Start Date :
Aug 6, 2020
Actual Primary Completion Date :
Jul 29, 2021
Actual Study Completion Date :
Jul 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: comfilcon A then samfilcon A

Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study.

Device: comfilcon A
Subjects will be randomized to wear comfilcon A for one month.
Other Names:
  • Biofinity Toric Multifocal

    • Device: Samfilcon A
    Subjects will be randomized to wear samfilcon A for one month.
    Other Names:
  • Ultra Multifocal for Astigmatism

    		•
    Active Comparator: samfilcon A then comfilcon A

    Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study.

    Device: comfilcon A
    Subjects will be randomized to wear comfilcon A for one month.
    Other Names:
  • Biofinity Toric Multifocal

    • Device: Samfilcon A
    Subjects will be randomized to wear samfilcon A for one month.
    Other Names:
  • Ultra Multifocal for Astigmatism

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ease of Lens Handling at Insertion [Day 28]

      Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Is at least 42 years of age and has full legal capacity to volunteer;

    2. Has read and signed an information consent letter;

    3. Self reports having a full eye examination in the previous two years;

    4. Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;

    5. Is willing and able to follow instructions and maintain the appointment schedule;

    6. Habitually wears soft contact lens for the past 3 months minimum;

    7. Has refractive astigmatism of at least -0.75DC;

    8. Is presbyopic and requires a reading addition of at least +0.75D;

    9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (sphere +4 to -6; cylinder -0.75 to -1.75DC; near addition +0.75 to +2.50).

    Exclusion Criteria:

    1. Is participating in any concurrent clinical or research study;

    2. Habitually wears one of the study contact lenses;

    3. Has any known active* ocular disease and/or infection;

    4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

    5. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;

    6. Has known sensitivity to the diagnostic sodium fluorescein and/or the care product Opti-Free PureMoist being used in the study;

    7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;

    8. Has undergone refractive error surgery. * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Athens Eye care Athens Ohio United States 45701
    2 Nittany Eye Associates State College Pennsylvania United States 16801
    3 Glasses Half Full Edmonton Alberta Canada T5N1S5
    4 Oakley Eyecare Winnipeg Manitoba Canada R2C 3B4
    5 Dolman Eyecare Centre New Hamburg Ontario Canada N3A 1K2
    6 Spadina Optometry Toronto Ontario Canada M5V 2K8
    7 Lyndon Jones Waterloo Ontorio Canada N2L 3G1

    Sponsors and Collaborators

    • Coopervision, Inc.

    Investigators

    • Principal Investigator: Lyndon Jones, PhD FCOptom, University of Waterloo
    • Principal Investigator: Fiona Soong, Eyes on Sheppard Clinic
    • Principal Investigator: Adam Keech, Oakley Eyecare
    • Principal Investigator: Howard Dolman, Dolman Eyecare Centre
    • Principal Investigator: Kristin Heeney, Spadina Optometry
    • Principal Investigator: Michael Kreuzer, Glasses Half Full
    • Principal Investigator: Shane Foster, Athens Eye Care
    • Principal Investigator: Michael Cymbor, Nittany Eye Associates

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT04404725
    Other Study ID Numbers:
    • EX-MKTG-110
    First Posted:
    May 27, 2020
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Feb 1, 2022
    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.:
    Yes
    Additional relevant MeSH terms:
    Astigmatism
    Presbyopia

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Of the 64 eligible participants, 63 were dispensed with study products, and one participant withdrew after the screening visit due to lens handling and general time commitment concerns.
    Arm/Group Title Comfilcon A Then Samfilcon A Samfilcon A Then Comfilcon A
    Arm/Group Description Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study. comfilcon A: Subjects will be randomized to wear comfilcon A for one month. Samfilcon A: Subjects will be randomized to wear samfilcon A for one month. Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study. comfilcon A: Subjects will be randomized to wear comfilcon A for one month. Samfilcon A: Subjects will be randomized to wear samfilcon A for one month.
    Period Title: First Intervention
    STARTED 32 31
    COMPLETED 32 29
    NOT COMPLETED 0 2
    Period Title: First Intervention
    STARTED 32 29
    COMPLETED 31 27
    NOT COMPLETED 1 2

    Baseline Characteristics

    Arm/Group Title Overall Study
    Arm/Group Description Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study. The baseline measures include information of all 64 eligible participants. Of the 64 eligible participants, 63 were dispensed with study products, and one participant withdrew after the screening visit due to lens handling and general time commitment concerns.
    Overall Participants 64
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    64
    100%
    >=65 years
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    53.9
    (8.9)
    Sex: Female, Male (Count of Participants)
    Female
    47
    73.4%
    Male
    17
    26.6%
    Race and Ethnicity Not Collected (Count of Participants)
    Region of Enrollment (participants) [Number]
    Canada
    48
    75%
    United States
    16
    25%

    Outcome Measures

    1. Primary Outcome
    Title Ease of Lens Handling at Insertion
    Description Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).
    Time Frame Day 28

    Outcome Measure Data

    Analysis Population Description
    Out of 58 subjects who completed the study, data of three participants from the comfilcon A Arm /group and data of two participants from samfilcon A Arm / group was excluded from the analysis due to minor protocol deviations.
    Arm/Group Title Comfilcon A Samfilcon A
    Arm/Group Description Subjects were randomized to wear comfilcon A for one month in this randomized, bilateral cross-over study. Subjects were randomized to wear samfilcon A for one month in this randomized, bilateral cross-over study.
    Measure Participants 55 56
    Mean (Standard Deviation) [score on a scale]
    8.6
    (1.6)
    8.8
    (1.8)

    Adverse Events

    Time Frame One month on each study lenses, a total of two months.
    Adverse Event Reporting Description
    Arm/Group Title Comfilcon A Samfilcon A
    Arm/Group Description Subjects were randomized to wear comfilcon A for one month in this randomized, bilateral cross-over study. Subjects were randomized to wear samfilcon A for one month in this randomized, bilateral cross-over study.
    All Cause Mortality
    Comfilcon A Samfilcon A
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/61 (0%) 0/63 (0%)
    Serious Adverse Events
    Comfilcon A Samfilcon A
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/61 (0%) 0/63 (0%)
    Other (Not Including Serious) Adverse Events
    Comfilcon A Samfilcon A
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 9/61 (14.8%) 9/63 (14.3%)
    Eye disorders
    conjunctivitis 5/61 (8.2%) 5 5/63 (7.9%) 5
    Infiltrative Keratitis 2/61 (3.3%) 2 0/63 (0%) 0
    General disorders
    Non-Ocular Event 2/61 (3.3%) 2 4/63 (6.3%) 4

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT 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/Title Jose Vega, OD, MSc, FAAO
    Organization CooperVision, Inc
    Phone 9256213761
    Email JVega2@coopervision.com
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT04404725
    Other Study ID Numbers:
    • EX-MKTG-110
    First Posted:
    May 27, 2020
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Feb 1, 2022