Positive one-year interim retrospective data on NaturalVue Multifocal 1 Day contact lenses, produced by Visioneering Technologies (VTI), has been presented at the American Academy of Optometry’s annual meeting in New Orleans.
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.
The multi-centre, randomised, double-masked clinical trial has participating investigators in Canada, the United States, Hong Kong, and Singapore. PROTECT is a three-year study, with interim analyses planned after the oneyear and two-year subject follow-ups.
Paediatric myopia is one of the most pressing concerns in optometry today
SEEING IS BELIEVING
The presentation entitled, ‘Seeing is believing: NaturalVue Multifocal one-year RCT myopia data preview and independent real-world retrospective studies data comparison’, was delivered by Dr Ashley Tuan, Chief Medical Officer for VTI.
Dr Tuan said the preliminary results 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 0.17mm, 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%.
RESULTS VALIDATE EXPECTATIONS
Dr Tuan said the preliminary data validates the company’s expectations of the safety and effectiveness of NaturalVue Multifocal contact lenses for paediatric patients.
“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 (the United States Food and Drug Administration) for myopia progression control, which we view as a positive result.”
Chief Executive Officer and Executive Director of VTI, Dr Juan Carlos Aragón, added: “Paediatric 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.
“The new interim results are outstanding and may support imminent partnering opportunities and commercial growth in key markets throughout Asia and Europe,” he said.
VTI reported that 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.
*Modified PP (Per Protocol) analysis including children between ages eight and<13 with refractive error between -0.75 and -4.00 D versus age- matched controls wearing spherical lenses. SD = standard deviation.