Overview
To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.
Description
This is a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type will be worn for approximately 4-6 weeks: the lens prescription of each lens type will be optimized after 3-10 days wearing experience, prior to starting a 1-month (28-32 days) wear period.
Eligibility
Inclusion Criteria:
- Is at least 42 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Self reports having a full eye examination in the previous two years;
- Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Habitually wears spherical multifocal soft contact lenses, for the past 3 months
minimum;
- Maximum of 4 participants (out of 12) per site may be habitual wearers of daily disposable lenses,
- Maximum of 4 participants (out of 12) per site may be habitual wearers of Biofinity Multifocal,
- Maximum of 4 participants (out of 12) per site may be habitual wearers of either TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal
- Has 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;
- Can 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:
- Is participating in any concurrent clinical or research trial;
- Has any known active ocular disease and/or infection that contraindicates contact lens wear;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
- Has known sensitivity to the diagnostic sodium fluorescein used in the study;
- Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- Has undergone refractive error surgery or intraocular surgery.