Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04404725
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
11.7
Actual Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • Device: comfilcon A
  • Device: Samfilcon A
N/A

Detailed Description

The objective of the study is 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 :
60 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

ArmIntervention/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. Lens Handling at Insertion [One month]

      Subjective at-home ratings 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

    SiteCityStateCountryPostal Code
    1Lyndon JonesWaterlooOntorioCanadaN2L 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 Nelson, Waverly Eye Care Centre & EyeGym
    • Principal Investigator: Michael Kreuzer, Glasses Half Full

    Study Documents (Full-Text)

    None provided.

    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:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    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:

    Study Results

    No Results Posted as of Oct 6, 2021