Visioneering Technologies, Inc presented the one-year interim retrospective data of its PROTECT randomized controlled (RCT) at the American Academy of Optometry’s annual meeting in New Orleans today. PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue® Multifocal Contact Lens Trial) was designed to demonstrate the safety and effectiveness of NaturalVue Multifocal Contact Lenses for myopia progression control in children.
This multi-center, randomized, double-masked clinical trial has participating investigators in Canada, the U.S., Hong Kong, and Singapore. PROTECT is a three-year study with interim analyses planned after the one-year and two-year subject follow-ups. One-year data from studies of similar design to PROTECT have been predictive of the three-year results. The final results of the study and any regulatory uses thereof will be based on the analysis of the complete three-year data set.
ONE-YEAR DATA
The presentation entitled, “Seeing is Believing: NaturalVue Multifocal 1-Year RCT Myopia Data Preview and Independent Real-World Retrospective Studies Data Comparison,” was delivered by Ashley Tuan, OD, Chief Medical Officer for VTI, who shared the first analysis of the RCT study results and recapped the NaturalVue Multifocal 1 Day real-world data.
Dr. Tuan reported preliminary one-year results that demonstrate the safety and efficacy of NaturalVue Multifocal 1 Day Contact Lenses in slowing myopia progression, providing an important data point for eye care practitioners. Based on a preliminary analysis of the one-year follow-up from 93% of the enrolled subjects in the PROTECT Clinical Trial*, the treatment effect with NaturalVue Multifocal 1 Day Contact Lenses was 0.41D, or 69% for refractive error, versus the control group. For axial length, the treatment effect was 0.17 mm, or 59%, versus the control group. Combined with the six-year data previously published in Clinical Ophthalmology in 2022 and the analyses from two other independent studies released in September 2023, this preliminary one-year data confirms that NaturalVue Multifocal effectively manages eye growth and refractive error change among progressing myopic children. To date, only six study subjects have voluntarily discontinued their participation, reflecting a low drop-out rate of 4%. The Company and the contract research organization conducting the study will continue to review and analyze the interim 1-year data set and plan to share additional details in January 2024.
“It’s exciting to see that the preliminary 1-year data validates our expectations of the safety and effectiveness of NaturalVue Multifocal Contact Lenses for pediatric patients. NaturalVue Multifocal 1 Day also provides clear vision for myopia correction and effectively slows myopia. The interim 1-year treatment effects are consistent with those of the only treatment approved by the FDA for myopia progression control, which we view as a positive result. We look forward to sharing more data from the study in the future,” says Dr. Tuan.
PRESSING CONCERN
VTI CEO and Executive Director Dr. Juan Carlos Aragón added, “Pediatric myopia is one of the most pressing concerns in optometry today, reaching epidemic proportions. VTI has been a pioneer in correcting myopia and protecting children with our innovative and easy-to-fit lens design. That’s why we’re excited to announce the 1-year interim results of our PROTECT Clinical Trial (RCT) that demonstrates the effectiveness of NaturalVue Multifocal 1 Day for myopia management in children.”
VTI expects to release longer-term data when available. To download a Fact Sheet summarizing the findings to date, click here.
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