Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

Not Applicable

Completed

Interventions: Device: Control Lens (comfilcon A)
Device: Test Lens (lehfilcon A)

Brief Summary: To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.

Detailed Description: This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 4-6 weeks: the lens prescription of each lens type was optimized after 3-10 days wearing experience, prior to starting a 1-month (28-32 days) 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 spherical multifocal soft contact lenses, for the past 3 months minimum:
- Maximum of 4 participants (out of 12) per site could be habitual wearers of daily disposable lenses,
- Maximum of 4 participants (out of 12) per site could be habitual wearers of Biofinity Multifocal,
- Maximum of 4 participants (out of 12) per site could be habitual wearers of either TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal
Had refractive astigmatism no higher than -0.75DC;
Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
Could be fit and achieve binocular distance vision of at least 20/30 Snellen which participants also deem to be 'acceptable', with the available study lens parameters (Distance sphere +4 to -6; near addition as per study design).

Exclusion Criteria

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 or ocular 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 affect contact lens wear or a study outcome variable;
Had known sensitivity to the diagnostic sodium fluorescein used in the study;
Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
Had undergone refractive error surgery or intraocular surgery.

Arm && Interventions

Group	Intervention	Description
Control Lens, then Test Lens	Control Lens (comfilcon A)	Participants will wear the Control Lens for 1 month, then the Test Lens for 1 month
Test Lens, then Control Lens	Test Lens (lehfilcon A)	Participants will wear the Test Lens for 1 month, then the Control Lens for 1 month
Test Lens, then Control Lens	Control Lens (comfilcon A)	Participants will wear the Test Lens for 1 month, then the Control Lens for 1 month
Control Lens, then Test Lens	Test Lens (lehfilcon A)	Participants will wear the Control Lens for 1 month, then the Test Lens for 1 month

Primary Outcome Measures

Name	Time	Method
Lens Handling for Insertion	1 month	Subjective rating collected in office using a 0-100 scale, where 0=Very difficult and 100=Very easy. The participant rated the study lens considering a typical day in the last 1 month of wear.

Secondary Outcome Measures

Name	Time	Method

Locations (5): Complete Eye Care of Medina
🇺🇸
Medina, Minnesota, United States
Sacco Eye Group
🇺🇸
Vestal, New York, United States
ProCare Vision Center
🇺🇸
Granville, Ohio, United States
Spadina Optometry
🇨🇦
Toronto, Ontario, Canada
New Bremen EyeCare
🇺🇸
New Bremen, Ohio, United States