Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

Completed · Not applicable

Conditions studied: Presbyopia

In brief

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

Key facts

Study ID

NCT05763628

Run by

CooperVision, Inc.

People needed

59

Starts

2022-12-10

Expected to finish

2023-06-15

Last updated by the study team

2024-07-08

Who can join

Age: 42 and older. Sex: any. Healthy volunteers: not accepted.

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 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
• Had refractive astigmatism no higher than -0.75DC in each eye;
• Were presbyopic and required a reading addition of at least +0.75D and no more than +2.50D;
• 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)

You may not qualify if…

• A person was excluded from the study if they:
• 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 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 affected contact lens wear or a study outcome variable;
• Had known sensitivity to the diagnostic sodium fluorescein to be used in the study;
• Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
• Had undergone refractive error surgery or interocular surgery.

Where it is running

• 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

Full record on ClinicalTrials.gov

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