January 22, 2024
LAS VEGAS — Visioneering Technologies Inc. (VTI) is sharing results from its ongoing PROTECT Trial (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial). The PROTECT Trial is a multi-national, double-masked, randomized controlled trial designed to demonstrate the safety and effectiveness of NaturalVue Multifocal 1 Day contact lenses (NVMF) for myopia progression control in children. PROTECT is a three-year study with interim analyses planned after the one-year and two-year marks.
VTI shared the latest results at the Global Specialty Lens Symposium with a presentation entitled, “Why Comparing RCT Data with Real-World Studies Is Important to Your Patients,” which was delivered by Dr. Ashley Tuan, Chief Medical Officer for VTI. Dr. Tuan reported new information from the one-year data set that 45% of subjects in the test group had no myopia progression at all and nearly two-thirds of subjects in the test group, or 64%, experienced no meaningful progression (defined as 0.25D or less per year).
Analysis of the full data set re-confirmed previously released results regarding axial length and refractive error change (minimal and insignificant changes noted). Children wearing NVMF contact lenses showed an average myopia change of 0.17D. The average refractive error reduction was 71%, or 0.41D vs. control group.* The average axial length reduction was 61%, or 0.17 mm vs. control group. Children wearing NVMF contact lenses showed an average axial length change of 0.11 mm.
Combined with the six-year data published in Clinical Ophthalmology (2022)1 and two other independent studies published in 2023,2,3 this one-year data supports that NVMF effectively manages eye growth and refractive error change among progressing myopic children in diverse populations and clinical settings. To date, a low drop-out rate of 4% was reported.
One-year data from studies of similar design to PROTECT have been predictive of the final three-year results. The PROTECT study data will continue to be reviewed and analyzed with additional details to be shared as available. The final results of the study and any regulatory uses thereof will be based on the analysis of the complete three-year data set.
“Further analysis of the full data set indicates that initial results announced in October are holding, further validating our confidence in the safety and effectiveness of NaturalVue Multifocal Contact Lenses for patients,” said Dr. Tuan. “NaturalVue Multifocal 1 Day also provides clear vision for myopia correction and effectively slows myopia. The interim one-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.”
“Now that we have the full data set analysis, we are excited that eye care professionals around the world have a strong myopia intervention that provides excellent vision for patients while also helping to slow the progression of their patients’ myopia,” said Chief Executive Officer and Executive Director of VTI, Dr. Juan Carlos Aragón.
VTI expects to release longer-term two- and three-year data when available. To download a Fact Sheet summarizing the findings to date, click here.
References
*Note: This reflects the one-year data set. The PROTECT study is ongoing and data will be reviewed, analyzed, and shared as available. Data is based on a modified PP (Per Protocol) analysis including children between ages 8 and <13 with refractive error between -0.75 and -4.00D 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.
- Cooper J, Aller T, Smith EL 3rd, Chan K, Dillehay SM, O’Connor B. Retrospective Analysis of a Clinical Algorithm for Managing Childhood Myopia Progression. Optom Vis Sci. 2023 Jan 1;100(1):117-124.
- Lederman, CR. Myopia Control With Extended Depth of Focus Multifocal Contact Lenses. In: American Association for Pediatric Ophthalmology and Strabismus; 2023 Mar 29; New York, USA.
- Walline JJ, Walker MK, Mutti DO, et al. Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial. JAMA. 2020;324(6):571–580. doi:10.1001/jama.2020.10834
