Evaluating Two Multifocal Daily Disposable Contact Lenses

Evaluating the Success of Refitting Lens Wearers With MyDay Multifocal, Who Are Already Adapted to Clariti 1Day Multifocal 2-Add Design

The objective of the study was to adapt existing multifocal soft lens wearers to a Control Lens for at least 2 weeks and then evaluate the success of switching them to the Test Lens, with a review after 2 weeks.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Control Lens; Device: Test Lens

Detailed Description

This prospective, bilateral eye, open label, non-randomized study compared the performance of 2 different designs of daily disposable multifocal contact lenses.

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

Contacts and Locations

• Study Contact: Name: Jose A Vega, OD MSc FAAO; Phone Number: 1-925-621-3761; Email: JVega2@coopervision.com

Study Locations

• United States
  • Florida
    • Ocoee, Florida, United States, 34761
      • Coan Eye Care & Optical Boutique
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • New York
    • Vestal, New York, United States, 13850
      • Sacco Eye Group
  • Ohio
    • Granville, Ohio, United States, 43023
      • ProCare Vision Center
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • Nittany Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

A person was eligible for inclusion in the study if he/she:

1. Was 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. Was willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wore multifocal soft contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens type was restricted such that no more than one third were to be the clariti 1 day multifocal and no more than one third were to be MyDay multifocal (this included their equivalent private label brand name);
7. Had refractive astigmatism no higher than -0.75DC in each eye;
8. Was presbyopic and required a reading addition of at least +0.75D and no more than +2.50D in each eye;
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)

Exclusion Criteria:

A person was excluded from the study if he/she:

1. Was 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. Was 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: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Lens; All participants wore the Control Lens for 2 weeks (Period 1)	Device: Control Lens; Daily disposable multifocal soft lens with 2 add design (2ADD) for 2 weeks
Experimental: Test Lens; All participants wore the Test Lens for 2 weeks (Period 2)	Device: Test Lens; Daily disposable multifocal soft lens with 3 add design (3ADD) for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort Just After Lens Insertion	Subjective rating measured on a scale of 0-10, 0.5 steps, where 0=Painful, 10=Can't feel the lenses.	2 weeks

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Collaborators: CORE
• Investigators: Principal Investigator: Shane Kannarr, Kannarr Eye Care; Principal Investigator: Michael Cymbor, Nittany Eye Associates; Principal Investigator: Andrew Sacco, Sacco Eye Group; Principal Investigator: Roxanne Achong-Coan, Coan Eye Care & Optical Boutique; Principal Investigator: Katherine Bickle, ProCare Vision Center

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): February 7, 2023
• Study Completion (Actual): February 7, 2023

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: EX-MKTG-140

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