January 24, 2022
ATLANTA — Visioneering Technologies Inc. announced that it has begun its international clinical trial that is designed to test the efficacy of its NaturalVue (etafilcon A) Multifocal 1-Day contact lenses on myopia control. The study, referred to as “PROTECT” (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial), is a multi-center, randomized, double-masked clinical trial with participating investigators in centers in Canada, the United States, and Hong Kong. The company announced that the first patient enrolled in the trial has already received the initial eye exam.
The trial is designed to enroll 144 healthy myopes of 7 to 13 years of age whose current prescription is between -0.75D and -5.00D. Participants will be randomly assigned to wear NaturalVue Sphere single-vision contact lenses (the control lens) or NaturalVue Multifocal contact lenses (the test lens). Primary outcomes will be determined by the changes in refractive error progression and eye length over time, both important markers of myopia progression. One-year follow-up data has been shown to be a strong predictor of the overall outcomes in other myopia control studies. VTI expects that the data will demonstrate the superiority of NaturalVue MF over the control in managing myopia progression, thus providing an important data point for practitioners and VTI’s corporate partnering activities. One-year follow-up data is expected to be released mid-2023, with longer-term data expected mid-2024 and mid-2025.
“With two billion myopes in the world, and five billion expected by 2050, now is a prime time for VTI to be at the forefront of innovation, development, and clinical validation in this industry,” said VTI’s Chief Medical Officer, Ashley Tuan, OD, PhD. “We are an early leader in the rapidly expanding area of myopia progression control, with safe and effective products that are available in over 11 countries. The results from PROTECT will allow us to have head-to-head comparison in terms of treatment effectiveness against other products that went through similarly designed multicentered studies. The results from PROTECT, starting with the one-year interim results in mid-2023, will add to our extensive real-world data, providing practitioners and parents with greater knowledge of their choices in the management of pediatric myopia.”
“Myopia is a pressing global health issue that negatively impacts the quality of life of billions of children, with up to 90% of children in some Asian nations, and over a quarter of children in the U.S. being myopic,” said VTI non-executive Chairman, David J. Mazzo. “Additionally, the degree of nearsightedness reached by the end of childhood correlates to a lifetime risk of blindness and other debilitating eye diseases, so limiting the progression of myopia in childhood is an important part of myopia management. We anticipate that the results of the PROTECT study, starting with the interim one-year data, will convince greater numbers of practitioners and parents worldwide to use NaturalVue MF as a key part of myopia management.”