- PROTECT multi-center, randomized, double-masked, controlled trial (RCT) 1-year patient follow-up clinical data corroborates the safety and efficacy of NaturalVue® Multifocal 1 Day Contact Lenses as a treatment for myopia progression control.
- The PROTECT study’s design and execution reflect the highest scientific standards for myopia progression control in pediatric patients.
- The treatment effect* was 0.41D (Diopters), 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.
- The interim 1-year treatment effects of the NaturalVue Multifocal 1 Day contact lenses are observed to be consistent with those of the only treatment approved by the U.S. Food and Drug Administration (FDA) for myopia progression control.
- This interim 1-year data corroborates the NaturalVue Multifocal 1 Day real-world data analyses.
Visioneering Technologies Inc or ‘VTI’ , the producer of the NaturalVue® Multifocal 1 Day Contact Lenses, presented the 1-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 United States, Hong Kong, and Singapore. PROTECT is a 3-year study with interim analyses planned after the 1-year and 2-year subject follow-ups. One-year data from studies of similar design to PROTECT have been predictive of the 3-year results. The final results of the study and any regulatory uses thereof will be based on the analysis of the complete 3-year data set.
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 Dr. Ashley Tuan, 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 1-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 1-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 6-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.
VTI Chief Medical Officer, Dr. Ashley Tuan, commented:
“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.”
Chief Executive Officer and Executive Director of VTI, 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.”
“This data release signals the beginning of a new chapter for VTI as we secure our place on the global map as a positive intervention option in myopia management. The new interim results are outstanding and may support imminent partnering opportunities and commercial growth in key markets throughout Asia and Europe.”
VTI expects to release longer-term 2- and 3-year data when available.
To download a Fact Sheet summarizing the findings to date, click here.
*Modified PP (Per Protocol) analysis including children between ages 8 and <13 with refractive error between -0.75 and -4.00 D versus age-matched controls wearing spherical lenses. SD = standard deviation
This information may describe uses for this product, i.e., Myopia Progression Control, which have not been approved by the FDA for use in the United States. It is intended for educational purposes only. NaturalVue® Multifocal is part of an ongoing randomized clinical trial (RCT) studying its effectiveness for myopia progression control. This information has been reviewed and approved by VTI’s Promotional Review Committee.