Visioneering Technologies, Inc, (VTI) will commence an international, multi-centre, randomised, double-masked clinical trial known as ‘PROTECT’ (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial).
The objective is to demonstrate and quantify the effectiveness of its NaturalVue Multifocal Contact Lenses (MF CL) in myopia progression control in children.
The trial enrolment includes 144 healthy nearsighted children (myopes) from seven to <13 years of age whose current prescription is between -0.75D and -5.00D. Primary outcomes will be determined by the respective changes over time in refractive error progression and eye length, both important markers of myopia progression. VTI expects the data will demonstrate the superiority of NaturalVue MF over the control lens in managing myopia progression, thus providing an important data point for practitioners and VTI’s corporate partnering activities and corroborating the conclusions of the recently reported analysis of six-year real-world data for NaturalVue MF.
In previous myopia control trials of this type, one-year follow-up data has been shown to be a strong predictor of overall trial outcomes. VTI expects to release one-year follow-up data from PROTECT in the fourth quarter of 2023, with longer-term data expected in late 2024 and final results in late 2025.
The study reached 100% enrolment, or all 144 subjects, on 6 December 2022. Importantly, there had been no safety concerns to date. Subjects are enrolled in sites in Toronto and Waterloo in Canada; New York, Chicago, Houston, and Fresno, CA in the United States; Hong Kong and Singapore.
