Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

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

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Control Lens (comfilcon A); Device: Test Lens (lehfilcon A)

Detailed 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.

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

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5V 3E7
      • Spadina Optometry
• United States
  • Minnesota
    • Medina, Minnesota, United States, 55364
      • Complete Eye Care of Medina
  • New York
    • Vestal, New York, United States, 13850
      • Sacco Eye Group
  • Ohio
    • Granville, Ohio, United States, 43023
      • ProCare Vision Center
    • New Bremen, Ohio, United States, 45869
      • New Bremen EyeCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 a week;
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 months minimum:

   • Maximum of 4 participants (out of 12) per site could be habitual wearers of daily disposable lenses,
   • Maximum of 4 participants (out of 12) per site could be habitual wearers of Biofinity Multifocal,
   • Maximum of 4 participants (out of 12) per site could be habitual wearers of either TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal
7. Had 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. Could 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. Were participating in any concurrent clinical or research study;
2. Had any known active ocular disease and/or infection that contraindicated contact lens wear;
3. Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
4. Were using any systemic or topical medications that in the opinion of the investigator 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 of enrolment;
7. Had 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 Lens, then Test Lens; Participants wore 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 wore 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	Subjective rating collected in office using a 0-100 scale, where 0=Very difficult and 100=Very easy. The participant rated the study lens considering a typical day in the last 1 month of wear.	1 month

Collaborators and Investigators

• Sponsor: CooperVision International Limited (CVIL)
• 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

Study Major Dates

• Study Start (Actual): February 23, 2024
• Primary Completion (Actual): July 9, 2024
• Study Completion (Actual): July 9, 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): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• 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