Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

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

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• 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: 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 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.

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 2 weeks, then crossed over to Test Lens for 2 weeks.	Device: Control Lens (stenfilcon A); Daily Disposable Multifocal Contact Lens for 2 weeks; Device: Test Lens (senofilcon A); Daily Disposable Multifocal Contact Lens for 2 weeks
Experimental: Test Lens, then Control Lens; Participants wore Test Lens for 2 weeks, then crossed over to Control Lens for 2 weeks.	Device: Control Lens (stenfilcon A); Daily Disposable Multifocal Contact Lens for 2 weeks; Device: Test Lens (senofilcon A); Daily Disposable Multifocal Contact Lens for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Handling for Removal	Subjective rating for ease of removal of the study lenses on a 0-100 scale, where 0=Very difficult and 100=Very easy. Collected once at the end of 2 weeks of wear.	2 Weeks

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Collaborators: Centre for Ocular Research & Education, Canada
• 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 (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• 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