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Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

Not Recruiting
42 years of age
Both
Phase N/A

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Overview

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

Description

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

Eligibility

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 spherical multifocal soft contact lenses, for the past 3 months minimum;
    • Maximum of 4 participants (out of 12) per site may be habitual wearers of daily disposable lenses,
    • Maximum of 4 participants (out of 12) per site may be habitual wearers of Biofinity Multifocal,
    • Maximum of 4 participants (out of 12) per site may be habitual wearers of either TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal
  7. Has refractive astigmatism no higher than -0.75DC;
  8. Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
  9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen which participants also deem to be 'acceptable', with the available study lens parameters (Distance sphere +4 to -6; near addition as per study design).

Exclusion Criteria:

  1. Is participating in any concurrent clinical or research trial;
  2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;
  3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
  5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
  6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
  7. Has undergone refractive error surgery or intraocular surgery.

Study details

Presbyopia

NCT06232590

Coopervision, Inc.

14 February 2025

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