PURPOSE:

Kalifilcon A (INFUSE/ULTRA One Day) multifocal silicone hydrogel daily disposable contact lenses (CLs) incorporate technology inspired by the Tear Film & Ocular Surface Society’s Dry Eye Workshop II Report and a three-zone progressive design to improve near and intermediate vision. The present analysis assessed fitting success in a multicenter clinical study conducted to evaluate the performance this CL.

METHODS:

Patients ≥40 years of age who were habitual wearers of soft multifocal contact lenses were enrolled in a prospective, single-arm, bilateral, open-label study conducted by investigators at 20 sites in the United States. All eligible subjects completed a screening/dispensing visit where they received study contact lenses for wear (3 weeks), with scheduled in-office follow-up visits at 1 week and 3 weeks. Investigators also completed a questionnaire (6-point Likert scale) at each subject’s study exit visit. A one-sided exact binomial test was used to evaluate rates of agreement with each questionnaire statement (hypothesis of agreement proportion >50%).

RESULTS:

Substantial proportions of the 294 subjects in this study (mean age 53.9 years; 78.2% female) were successfully fit with this lens in one visit (87.4%, screening/dispensing) or two visits (99.0%, screening/dispensing+1 week follow-up). By eye, these proportions with successful fits were 91.4% and 99.0%, respectively. At the screening/dispensing visit, 93.0% of eyes and 89.5% of subjects required no lens refinement to achieve a successful fit, with consistent findings at 1 week. Across all visits, 85.9% of eyes required no lens refinement. In the study investigator questionnaire, practitioners also expressed agreement that the fitting process was straightforward for all (100%) subjects (p <0.0001), with nearly two thirds 67.8 even strongly agreeing with this statement.>

CONCLUSION:

This multifocal silicone hydrogel daily disposable CL demonstrated strong fitting performance in a variety of subjects, as evidenced by both fitting success rates and practitioner responses.