Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

April 2, 2024 updated by: Coopervision, Inc.
To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5V 3E7
  • United States
    • Minnesota
      • Medina, Minnesota, United States, 55364
    • New York
      • Vestal, New York, United States, 13850
    • Ohio
      • Granville, Ohio, United States, 43023
        • Recruiting
        • ProCare Vision Center
        • Contact:
          • Katherine Bickle
        • Contact:
      • New Bremen, Ohio, United States, 45869

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control Lens, then Test Lens
Participants will wear the Control Lens for 1 month, then the Test Lens for 1 month
Device: Control Lens (comfilcon A)
Multifocal monthly replacement contact lens for 1 month
Device: Test Lens (lehfilcon A)
Multifocal monthly replacement contact lens for 1 month
Experimental: Test Lens, then Control Lens
Participants will wear the Test Lens for 1 month, then the Control Lens for 1 month
Device: Control Lens (comfilcon A)
Multifocal monthly replacement contact lens for 1 month
Device: Test Lens (lehfilcon A)
Multifocal monthly replacement contact lens for 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lens Handling for Insertion
Time Frame: 1 month
Subjective rating at study visit will be measured using a 0-100 scale, where 0=Very difficult and 100=Very easy
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coopervision, Inc.

Collaborators

Centre for Ocular Research & Education, Canada

Investigators

  • Principal Investigator: Gina Wesley, Complete Eye Care of Medina
  • Principal Investigator: David Wilkinson, Spadina Optometry
  • Principal Investigator: Andrew Sacco, Sacco Eye Group
  • Principal Investigator: Katherine Bickle, ProCare Vision Center
  • Principal Investigator: Dustin Gardner, New Bremen EyeCare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX-MKTG-153

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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