KEY CLINICAL STUDY DATA: A multicenter, single-arm, open-label study was conducted to assess the safety and effectiveness of the Arise system over a 3-month period. Patient population: Ortho-K lens-naïve patients ≥12 years of age, with myopic refractive error (spherical refractive error between plano and -5.00 D, astigmatism ≤1.50 D, and a corneal topography sagittal height differential of ≥30 µm).

KEY EFFECTIVENESS OUTCOMES: Primary effectiveness outcome: following 3 months of overnight lens wear, 93.3% of patients achieved a monocular high-contrast uncorrected distance visual acuity (UDVA) of 20/40 or better (95% CI: 82.1%, 97.7%; n=45 patients). Improvements in UDVA line change were observed at each follow-up visit compared with baseline. Mean (SD) UDVA line change from baseline at the 3-month follow-up visit was 5.9 (3.3); n=90 eyes. Acceptable lens fit was reported for 96.1% of eyes at the first dispensing visit (n=152 eyes). Following the first night of overnight wear, acceptable lens fit assessments were reported for 95.5% of eyes (n=132).

KEY SAFETY OUTCOMES: Primary safety outcome: no serious adverse events were reported throughout the study, including treatment-emergent serious adverse events. The safety profile was consistent with previous studies of overnight Ortho-K lenses, with no new potential safety risks identified.

CONCLUSIONS: These findings were in line with those of an earlier multicenter, 9-month study of oprifocon A lenses in 191 patients (374 eyes) with myopia ≥18 years of age.