Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

Not Applicable

Completed

• Conditions: Presbyopia

• Registration Number: NCT05763628
• Lead Sponsor: Coopervision, Inc.

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.

Study Timeline

• Study Start: 2022-12-10
• Study First Submitted: 2023-02-21
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-10
• Primary Completion: 2023-06-15
• Study Completion: 2023-06-15
• Results First Submitted: 2024-06-10
• Results First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Results First Posted: 2024-07-08
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Lens Handling for Removal	2 Weeks	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.

Trial Locations

Locations (5)

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