December 7, 2022
The study objective is to demonstrate and quantify the effectiveness of VTI’s NaturalVue Multifocal Contact Lenses for myopia progression control in children. PROTECT is a multi-center, randomized, double-masked clinical trial with participating investigators in centers in Canada, the United States, Hong Kong, and Singapore.
The trial enrollment includes 144 healthy nearsighted children (myopes) from 7 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 that the data will demonstrate the superiority of the NaturalVue Multifocal 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 Multifocal.
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% enrollment, or all 144 subjects, on December 6, 2022. Importantly, there have been no safety concerns to date. The landmark study has enrolled subjects in sites in Toronto and Waterloo in Canada; New York, Chicago, Houston, and Fresno, California, in the United States, as well as in Hong Kong and Singapore.
“The principal investigators at our existing sites have embraced the PROTECT Clinical Study,” said Ashley Tuan, OD, PhD, VTI’s Chief Medical Officer. “We believe the results of the PROTECT Clinical Study will corroborate our real-world data that showed a significant positive impact of NaturalVue Multifocal, making it an excellent choice for the management of myopia. We greatly appreciate the efforts of those independent eye care professionals serving as principal investigators in this study and their commitment to providing the highest quality evidence of the effectiveness of this outstanding product. I look forward to sharing interim one-year results in late 2023.”