Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

NCT ID: NCT06232590

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-23
• Study Completion Date: 2024-07-09

Brief Summary

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

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.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Lens, then Test Lens

Participants wore Control Lens for 1 month, then the Test Lens for 1 month

Group Type: EXPERIMENTAL

Control Lens (comfilcon A)

Intervention Type: DEVICE

Multifocal monthly replacement contact lens for 1 month

Test Lens (lehfilcon A)

Intervention Type: DEVICE

Multifocal monthly replacement contact lens for 1 month

Test Lens, then Control Lens

Participants wore the Test Lens for 1 month, then the Control Lens for 1 month

Group Type: EXPERIMENTAL

Control Lens (comfilcon A)

Intervention Type: DEVICE

Multifocal monthly replacement contact lens for 1 month

Test Lens (lehfilcon A)

Intervention Type: DEVICE

Multifocal monthly replacement contact lens for 1 month

Interventions

Control Lens (comfilcon A)

Multifocal monthly replacement contact lens for 1 month

Intervention Type: DEVICE

Test Lens (lehfilcon A)

Multifocal monthly replacement contact lens for 1 month

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 42 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Ocular Research & Education, Canada

OTHER

Sponsor Role: collaborator

CooperVision International Limited (CVIL)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Sacco

Role: PRINCIPAL_INVESTIGATOR

Sacco Eye Group

David Wilkinson

Role: PRINCIPAL_INVESTIGATOR

Spadina Optometry

Katherine Bickle

Role: PRINCIPAL_INVESTIGATOR

ProCare Vision Center

Dustin Gardner

Role: PRINCIPAL_INVESTIGATOR

New Bremen EyeCare

Gina Wesley

Role: PRINCIPAL_INVESTIGATOR

Complete Eye Care of Medina

Locations

Complete Eye Care of Medina

Medina, Minnesota, United States

Sacco Eye Group

Vestal, New York, United States

ProCare Vision Center

Granville, Ohio, United States

New Bremen EyeCare

New Bremen, Ohio, United States

Spadina Optometry

Toronto, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-153

Identifier Type: -

Identifier Source: org_study_id