Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

The objective of the study is to compare the lens performance of two daily disposable multifocal contact lenses.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Control Contact Lens (stenfilcon A Daily Disposable Multifocal Contact Lens); Device: Test Contact Lens (senofilcon A Daily Disposable Multifocal Contact Lens)

Detailed Description

This is a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type will be worn for approximately 3-4 weeks: the lens prescription of each lens type will be optimized after 3-8 days wearing experience, prior to starting a 2-week (14-21 day) wear period.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2N 3A1
      • Eyes on Sheppard Clinic
    • Toronto, Ontario, Canada, M5V 3E7
      • Spadina Optometry
• United States
  • New York
    • Vestal, New York, United States, 13850
      • Sacco Eye Group PLLC
  • Ohio
    • Athens, Ohio, United States, 45701
      • Athens Eye Care- Dr. Shane Foster & Associates
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Family Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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^;

  • Maximum of 7 participants per site should be habitual wearers of daily disposable lenses

    • Maximum of 3 habitual wearers per site of 1-Day Acuvue Moist Multifocal
    • Maximum of 1 habitual wearer per site of ACUVUE OASYS MAX 1-Day MULTIFOCAL
    • Maximum of 3 habitual wearers per site of MyDay Multifocal

  • Maximum of 7 participants per site should be habitual wearers of frequent replacement lenses

    • Maximum of 1 habitual wearer per site of ACUVUE OASYS for PRESBYOPIA
• Has refractive astigmatism no higher than -0.75DC;
• Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
• 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 (Distance sphere +4 to -6; near addition as per study design).

Exclusion Criteria:

• Is participating in any concurrent clinical or research trial;
• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control Contact Lens, Then Test Contact Lens; Participants will wear control contact lenses for two weeks and then crossover to test contact lenses for two weeks.	Device: Control Contact Lens (stenfilcon A Daily Disposable Multifocal Contact Lens); two weeks of wear; Device: Test Contact Lens (senofilcon A Daily Disposable Multifocal Contact Lens); two weeks of wear
Experimental: Test Contact Lens, Then Control Contact Lens; Participants will wear test contact lenses for two weeks and then crossover to control contact lenses for two weeks.	Device: Control Contact Lens (stenfilcon A Daily Disposable Multifocal Contact Lens); two weeks of wear; Device: Test Contact Lens (senofilcon A Daily Disposable Multifocal Contact Lens); two weeks of wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Handling for Removal	Lens Handling for Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)	2 weeks of wear

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Collaborators: CORE
• Investigators: Principal Investigator: Fiona Soong, Eyes on Sheppard Clinic; Principal Investigator: David Wilkinson, Spadina Optometry; Principal Investigator: Ashley Tucker, Bellaire Family Eye Care; Principal Investigator: Shane Foster, Athens Eye Care - Dr. Shane Foster & Associates; Principal Investigator: Andrew Sacco, Sacco Eye Group PLLC

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: EX-MKTG-144

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