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

Abstract

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.