Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

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.

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.