Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

Not Applicable

Completed

Interventions: Device: Control Lens (stenfilcon A)
Device: Test Lens (senofilcon A)

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.

Recruitment & Eligibility

Inclusion Criteria

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)

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Control Lens, then Test Lens	Control Lens (stenfilcon A)	Participants wore Control Lens for 2 weeks, then crossed over to Test Lens for 2 weeks.
Control Lens, then Test Lens	Test Lens (senofilcon A)	Participants wore Control Lens for 2 weeks, then crossed over to Test Lens for 2 weeks.
Test Lens, then Control Lens	Control Lens (stenfilcon A)	Participants wore Test Lens for 2 weeks, then crossed over to Control Lens for 2 weeks.
Test Lens, then Control Lens	Test Lens (senofilcon A)	Participants wore Test Lens for 2 weeks, then crossed over to Control Lens for 2 weeks.

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.

Secondary Outcome Measures

Name	Time	Method

Locations (5): Sacco Eye Group PLLC
🇺🇸
Vestal, New York, United States
Athens Eye Care- Dr. Shane Foster & Associates
🇺🇸
Athens, Ohio, United States
Spadina Optometry
🇨🇦
Toronto, Ontario, Canada
Eyes on Sheppard Clinic
🇨🇦
Toronto, Ontario, Canada
Bellaire Family Eye Care
🇺🇸
Bellaire, Texas, United States