Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

NCT06232590 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-153
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Lens, then Test Lens

EXPERIMENTAL

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

Device: Control Lens (comfilcon A); Device: Test Lens (lehfilcon A)

Test Lens, then Control Lens

EXPERIMENTAL

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

Device: Control Lens (comfilcon A); Device: Test Lens (lehfilcon A)

Interventions

Control Lens (comfilcon A) DEVICE

Multifocal monthly replacement contact lens for 1 month

Control Lens, then Test Lens; Test Lens, then Control Lens

Test Lens (lehfilcon A) DEVICE

Multifocal monthly replacement contact lens for 1 month

Control Lens, then Test Lens; Test Lens, then Control Lens

Eligibility Criteria

• Age: 42 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Were at least 42 years of age and had full legal capacity to volunteer;
• Had read and signed an information consent letter;
• Self-reported having had a full eye examination in the previous two years;
• Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week;
• Were willing and able to follow instructions and maintain the appointment schedule;
• 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
• Had 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;
• 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).

You may not qualify if:

• Were participating in any concurrent clinical or research study;
• Had any known active ocular disease and/or infection that contraindicated contact lens wear;
• Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
• 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;
• Had known sensitivity to the diagnostic sodium fluorescein used in the study;
• Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
• Had undergone refractive error surgery or intraocular surgery.

Sponsors & Collaborators

• CooperVision International Limited (CVIL): lead
• Centre for Ocular Research & Education, Canada: collaborator

Study Sites (5)

Complete Eye Care of Medina

Medina, Minnesota, 55364, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

New Bremen EyeCare

New Bremen, Ohio, 45869, United States

Location

Spadina Optometry

Toronto, Ontario, M5V 3E7, Canada

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: José A. Vega
• Organization: CooperVision Inc.

JVega2@coopervision.com

+1 (925) 621-3761

Study Officials

• Andrew Sacco

  Sacco Eye Group

  PRINCIPAL INVESTIGATOR

• David Wilkinson

  Spadina Optometry

  PRINCIPAL INVESTIGATOR

• Katherine Bickle

  ProCare Vision Center

  PRINCIPAL INVESTIGATOR

• Dustin Gardner

  New Bremen EyeCare

  PRINCIPAL INVESTIGATOR

• Gina Wesley

  Complete Eye Care of Medina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: February 23, 2024
• Primary Completion: July 9, 2024
• Study Completion: July 9, 2024
• Last Updated: February 12, 2025
• Results First Posted: February 12, 2025

Record last verified: 2024-11

Locations

CA (1); US (4)