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Evaluating Two Multifocal Daily Disposable Contact Lenses

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05579886
Collaborator
(none)
51
Enrollment
1
Location
2
Arms
4.1
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the study is to adapt existing multifocal soft lens wearers to a CONTROL lens for at least 2 weeks and then evaluate the success of switching them to the TEST lens, with a review after 2 weeks.

Condition or Disease Intervention/Treatment Phase
  • Device: Control Contact Lens
  • Device: Test Contact Lens
 N/A

Detailed Description

This is a prospective, bilateral eye, open label, daily wear switch study involving daily disposable multifocal lenses. There will be no randomisation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
51 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluating the Success of Refitting Lens Wearers With MyDay Multifocal, Who Are Already Adapted to Clariti 1Day Multifocal 2-Add Design
Actual Study Start Date :
Sep 13, 2022
Anticipated Primary Completion Date :
Jan 15, 2023
Anticipated Study Completion Date :
Jan 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control Contact Lens

Subjects will wear Control contact lens for the first period of 2 weeks (14-21 days) and Test contact lens for the second period of 2 weeks (14-21 days).

Device: Control Contact Lens
Control Contact Lens - first period of 2 weeks (14-21 days)
Other Names:
  • Multifocal Daily Disposable Contact Lens

    		•
    Experimental: Test Contact Lens

    Subjects will wear Test contact lens for the second period of 2 weeks (14-21 days).

    Device: Test Contact Lens
    Test Contact Lens - second period of 2 weeks (14-21 days)
    Other Names:
  • Multifocal Daily Disposable Contact Lens

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comfort Just After Lens Insertion [2 weeks]

      Comfort Just After Lens Insertion will be measured on a scale of 0-10 ratings, where 0=Painful, 10=Can't feel the lenses

    Eligibility Criteria

    Criteria

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

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

    • Has read and signed an information consent letter;

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

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

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

    • Habitually wears multifocal soft contact lenses, for the past 3 months minimum;

    • Has refractive astigmatism no higher than -0.75DC in each eye;

    • Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D in each eye;

    • 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 (powers +4.00 to -6.00DS)

    Exclusion Criteria:

    • Is participating in any concurrent clinical or research study;

    • Has any known active* ocular disease and/or infection that contraindicates contact lens wear;

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

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

    • Has known sensitivity to the diagnostic sodium fluorescein used in the study;

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

    • Has undergone refractive error surgery or intraocular surgery.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CORE, University of Waterloo, Canada Waterloo Ontario Canada N2L 3G1

    Sponsors and Collaborators

    • Coopervision, Inc.

    Investigators

    • Study Director: Lyndon Jones, PhD FCOptom, Centre for Ocular Research and Education

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT05579886
    Other Study ID Numbers:
    • EX-MKTG-140
    First Posted:
    Oct 14, 2022
    Last Update Posted:
    Oct 14, 2022
    Last Verified:
    Oct 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:
    Presbyopia

    Study Results

    No Results Posted as of Oct 14, 2022