Randomised controlled trial of HOYA one-day multifocal contact lenses: The HOMCL trial.

TRIAL DESIGN

Double-masked crossover RCT (Research Registry: #8136) comparison of a new HOYA one-day disposable multifocal contact lens (HOMCL) with Alcon DAILIES TOTAL1® Multifocal (ADT1).

METHODS

Sixty presbyopic participants from three countries attended for baseline measurements and fitting of both lens types and then for a fortnight completed daily diaries of symptoms with habitual optical correction, and VF-14 questionnaire. Participants collected either HOMCL or ADT1, when the vision was measured again, and they wore this product for a fortnight, completing daily diaries and VF-14. Participants then collected the other type and had vision and symptoms recorded in the same way.

RESULTS

There were no serious adverse events. Primary outcomes were no significant differences between the lens types in willingness to purchase nor stated preference; no significant differences in the daily symptom ratings of comfort; statistically significant findings with the daily symptom ratings and VF-14 of better near vision with HOMCL and better distance vision with ADT1. Secondary outcomes were better high contrast distance visual acuity with ADT1 (<1 line), better low contrast distance visual acuity with ADT1; faster Wilkins rate of reading test with HOMCL; no significant differences in near visual acuity, wearing time, or number of lenses required during fitting process. Exploratory analyses were better handling scores with ADT1; and some, but not all of the dry eye data indicating better acceptance of HOMCL by patients with relatively dry eyes. For all measures, there were some participants who preferred/performed better with each lens type.

CONCLUSIONS

The differences between the performance of the two products were small. There was a trend in some clinical measurements and the daily diary data and VF-14 questionnaire, for HOMCL to outperform ADT1 for near vision and vice versa for distance vision.