Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

NCT ID: NCT05763628

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-10
• Study Completion Date: 2023-06-15

Brief Summary

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

Detailed Description

This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 3-4 weeks: the lens prescription of each lens type was optimized after a 3-8 days wearing experience, then participants began a 2 week (14-21 day) 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 2 weeks, then crossed over to Test Lens for 2 weeks.

Group Type: EXPERIMENTAL

Control Lens (stenfilcon A)

Intervention Type: DEVICE

Daily Disposable Multifocal Contact Lens for 2 weeks

Test Lens (senofilcon A)

Intervention Type: DEVICE

Daily Disposable Multifocal Contact Lens for 2 weeks

Test Lens, then Control Lens

Participants wore Test Lens for 2 weeks, then crossed over to Control Lens for 2 weeks.

Group Type: EXPERIMENTAL

Control Lens (stenfilcon A)

Intervention Type: DEVICE

Daily Disposable Multifocal Contact Lens for 2 weeks

Test Lens (senofilcon A)

Intervention Type: DEVICE

Daily Disposable Multifocal Contact Lens for 2 weeks

Interventions

Control Lens (stenfilcon A)

Daily Disposable Multifocal Contact Lens for 2 weeks

Intervention Type: DEVICE

Test Lens (senofilcon A)

Daily Disposable Multifocal Contact Lens for 2 weeks

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 multifocal soft contact lenses, for the past 3 months minimum

• Maximum of 7 participants per site were 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 were habitual wearers of frequent replacement lenses
• Maximum of 1 habitual wearer per site of ACUVUE OASYS for PRESBYOPIA

7. Had refractive astigmatism no higher than -0.75DC in each eye;

8. Were presbyopic and required a reading addition of at least +0.75D and no more than +2.50D;

9. Could be fit and achieved binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS, near addition as per study design)

Exclusion Criteria

A person was excluded from the study if they:

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 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 affected contact lens wear or a study outcome variable;

5. Had known sensitivity to the diagnostic sodium fluorescein to be 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 interocular 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, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Wilkinson

Role: PRINCIPAL_INVESTIGATOR

Spadina Optometry

Ashley Tucker

Role: PRINCIPAL_INVESTIGATOR

Bellaire Family Eye Care

Fiona Soong

Role: PRINCIPAL_INVESTIGATOR

Eyes on Sheppard Clinic

Andrew Sacco

Role: PRINCIPAL_INVESTIGATOR

Sacco Eye Group PLLC

Shane Foster

Role: PRINCIPAL_INVESTIGATOR

Athens Eye Care - Dr. Shane Foster & Associates

Locations

Sacco Eye Group PLLC

Vestal, New York, United States

Athens Eye Care- Dr. Shane Foster & Associates

Athens, Ohio, United States

Bellaire Family Eye Care

Bellaire, Texas, United States

Eyes on Sheppard Clinic

Toronto, Ontario, Canada

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-144

Identifier Type: -

Identifier Source: org_study_id