Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

Last updated: January 21, 2025
Sponsor: CooperVision International Limited (CVIL)
Overall Status: Completed

Phase

N/A

Condition

Presbyopia

Treatment

Control Lens (comfilcon A)

Test Lens (lehfilcon A)

Clinical Study ID

NCT06232590
EX-MKTG-153
  • Ages > 42
  • All Genders

Study Summary

To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Were at least 42 years of age and had full legal capacity to volunteer;

  2. Had read and signed an information consent letter;

  3. Self-reported having had a full eye examination in the previous two years;

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

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

  6. Habitually wore spherical multifocal soft contact lenses, for the past 3 monthsminimum:

  • Maximum of 4 participants (out of 12) per site could be habitual wearers ofdaily disposable lenses,

  • Maximum of 4 participants (out of 12) per site could be habitual wearers ofBiofinity Multifocal,

  • Maximum of 4 participants (out of 12) per site could be habitual wearers ofeither TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal

  1. Had refractive astigmatism no higher than -0.75DC;

  2. Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;

  3. Could be fit and achieve binocular distance vision of at least 20/30 Snellen whichparticipants also deem to be 'acceptable', with the available study lens parameters (Distance sphere +4 to -6; near addition as per study design).

Exclusion

Exclusion Criteria:

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

  2. Had any known active ocular disease and/or infection that contraindicated contactlens wear;

  3. Had a systemic or ocular condition that in the opinion of the investigator may haveaffected a study outcome variable;

  4. Were using any systemic or topical medications that in the opinion of theinvestigator may have affect contact lens wear or a study outcome variable;

  5. Had known sensitivity to the diagnostic sodium fluorescein used in the study;

  6. Self-reported as pregnant, lactating or planning a pregnancy at the time ofenrolment;

  7. Had undergone refractive error surgery or intraocular surgery.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Control Lens (comfilcon A)
Phase:
Study Start date:
February 23, 2024
Estimated Completion Date:
July 09, 2024

Study Description

This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 4-6 weeks: the lens prescription of each lens type was optimized after 3-10 days wearing experience, prior to starting a 1-month (28-32 days) wear period.

Connect with a study center

  • Spadina Optometry

    Toronto, Ontario M5V 3E7
    Canada

    Site Not Available

  • Complete Eye Care of Medina

    Medina, Minnesota 55364
    United States

    Site Not Available

  • Sacco Eye Group

    Vestal, New York 13850
    United States

    Site Not Available

  • ProCare Vision Center

    Granville, Ohio 43023
    United States

    Site Not Available

  • New Bremen EyeCare

    New Bremen, Ohio 45869
    United States

    Site Not Available

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