May 6, 2024
Photo Credit: Marcus Lindstrom, iStock
SEATTLE, Wash. — Visioneering Technologies Inc. has shared the latest data from its PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial) clinical trial at the Association for Research in Vision and Ophthalmology (ARVO) meeting. The PROTECT trial was 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 involving 145 children with analyses planned after the one-year and two-year marks.
Dr. Ashley Tuan, Chief Medical Officer for VTI, presented new data from the PROTECT trial that focused on details of axial length and wearing time. Dr. Tuan also summarized data released earlier in the year on refractive error change and reduction. The poster entitled, “A Randomized Controlled Trial for Myopia Progression Control Using Catenary Power Profile Contact Lenses: 12-month Effectiveness and Safety,” was prepared by Dr. Tuan and Dr. Sally Dillehay.
The new data that outlines the distribution of change in axial length (mm) in patients showed that 58% of patients wearing NaturalVue had axial growth similar to age-matched emmetropic children. This data point, especially when paired with the previously released distribution of change in refractive error (D) data showing that two-thirds of patients, or 64%, experienced no meaningful progression of myopia (defined as -0.25D or less of progression) further suggests NaturalVue Multifocal may effectively manage myopia among children under diverse clinical settings and populations.
Compliance is believed to be essential for myopia control success and is influenced by the quality of vision and comfort.1 Given that children on average wore NaturalVue for 11-12 hours per day is indicative that the lens provides excellent vision and comfort and a positive quality of life experience. VTI believes that these factors contributed to the positive results seen thus far in the PROTECT study.
In addition to the new learnings listed above, the one-year data set has revealed the following results thus far:
- 45% of patients had no progression (change <= 0 Diopters (“D”)) and ~two-thirds of patients or 64% experienced no meaningful progression of myopia (defined as -0.25D or less of progression per year).
- 71% or (0.41D) reduction in refractive error progression, versus the control group.
- Children wearing NaturalVue Multifocal contact lenses showed an average refractive error change of 0.18D.
- 0.17 mm or 61% average reduction in axial elongation, versus the control group.
- The average axial length change in children wearing NaturalVue Multifocal contact lenses was 0.11 mm.
One-year data from studies of similar design to PROTECT have been predictive of the final three-year results.2 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.
“For the majority of patients, the study showed that NaturalVue held axial length growth to that of age-matched emmetropic children,” said Dr. Tuan. “Additionally, the wearing time results are important, as these are directly related to the results seen across the study. These new data continue to validate our confidence in the effectiveness of NaturalVue Multifocal Contact Lenses. VTI will continue to mine the study and share results with the industry and eye care practitioners around the world.”
“As we continue to glean new learnings from this extensive data set, it is evident that NaturalVue represents a powerful tool for eye care practitioners to use to manage myopia,” said CEO and Executive Director of VTI, Dr. Juan Carlos Aragón. “These results should provide confidence to both eye care practitioners and parents that NaturalVue will provide excellent vision for patients while also helping to slow the progression of patients’ myopia.”
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.
* Note: This reflects the one-year data set. The PROTECT study is ongoing, and data will be reviewed, analyzed, and shared as available. Data presented here are limited by the range of age, race, geographical locations, and study duration. Data is based on a modified PP (Per Protocol) analysis including children between ages 8 and <13 with refractive error between -0.75D 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.
References
- Bullimore MA, Jong M, Brennan NA. Myopia control: Seeing beyond efficacy. Optom Vis Sci. 2024 Mar 1;101(3):134-142. doi: 10.1097/OPX.0000000000002119. PMID: 38546754.
- Brennan N, Toubouti Y, Cheng X et al. Efficacy in myopia control. Progress in Retinal and Eye Research 83 (2021) 100923
