Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

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

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:

1. Were at least 42 years of age and had full legal capacity to volunteer;

2. Had read and signed an information consent letter;

3. Self-reported having had a full eye examination in the previous two years;

4. Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week;

5. Were willing and able to follow instructions and maintain the appointment schedule;

6. 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

7. Had refractive astigmatism no higher than -0.75DC;

8. Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;

9. 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:

1. Were participating in any concurrent clinical or research study;
2. Had any known active ocular disease and/or infection that contraindicated contact lens wear;
3. Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
4. 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;
5. Had known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Had undergone refractive error surgery or intraocular surgery.