Latest Myopia News

VTI Reaches 50% Enrollment Milestone for PROTECT Study

July 13, 2022

ATLANTA – Medical device company and producer of NaturalVue Multifocal 1 Day Contact Lenses, Visioneering Technologies, Inc (ASX:VTI) announced it has enrolled 50% of the subjects in its international randomized controlled clinical trial known as “PROTECT(PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial).

The study objective is to demonstrate and quantify the effectiveness of its NaturalVue Multifocal Contact Lenses in 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, and Hong Kong, with an additional site planned in Singapore.

The trial is designed to enroll 144 healthy myopic children 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 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.

VTI expects to complete trial enrollment in September 2022. 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 second half of 2023, with longer-term data expected in the second half of 2024 and final results in the second half of 2025.

The study reached 50% enrollment, or 72 subjects, on July 12, 2022. There have been no safety concerns to date. The landmark study has enrolled subjects in sites in Toronto and Waterloo in Canada; Hong Kong; and in New York, Chicago, Houston, and Fresno, Calif., in the United States.

VTI’s Chief Medical Officer, Ashley Tuan, OD, PhD, commented, “The principal investigators at our existing sites have embraced the PROTECT Clinical Study. We are pleased with the progress to date and look forward to adding our final site and reaching full enrollment. 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.”

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