Home News New Data from VTI’s PROTECT Clinical Trial for Myopia Progression Control Presented...

New Data from VTI’s PROTECT Clinical Trial for Myopia Progression Control Presented at ARVO

58% of patients had similar physiological axial length growth as age-related emmetropic children

Visioneering Technologies, producer of the NaturalVue® Multifocal 1 Day Contact Lenses (NVMF), continued its release of the 1-year prospective data of its ongoing multi-center, randomized, double-masked, controlled trial at the Association for Research in Vision and Ophthalmology (ARVO).

THE STUDY

PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial) was designed to demonstrate the safety and effectiveness of NVMF for myopia progression control in children. PROTECT is a three-year study involving 145 children with analyses planned after the 1-year and 2-year marks.

Results from the 1-year data set

Dr. Tuan
Dr. Tuan

Ashley Tuan, OD, 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. She and Sally Dillehay, OD, EdD, prepared the poster entitled, “A Randomized Controlled Trial for Myopia Progression Control Using Catenary Power Profile Contact Lenses: 12-month Effectiveness and Safety.”

Dr. Dillehay
Dr. 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 release distribution of change in refractive error (D) data showing that 2/3 of patients or 64% experienced no meaningful progression of myopia (defined as -0.25 D or less of progression) further suggests NaturalVue Multifocal may effectively manage myopia among children under diverse clinical settings and populations.

Many believe compliance is 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 did contribute to the positive results seen thus far in the PROTECT study.

MORE FINDINGS

In addition to the new learnings listed above, the 1-year data set has revealed the following results thus far:

  • 45% of patients had no progression (change <= 0 Diopters (“D”)) and ~2/3 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 0.18 D.
  • 17mm 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 3-year results.2 Researchers will continue to review and analyze the PROTECT study data and share additional details as available. The final results  and any regulatory uses will rely on the analysis of the complete three-year data set.

HEAR FROM THE TEAM

“For the majority of patients, the study showed that NaturalVue held axial length growth to that of age-matched emmetropic children,” Dr. Tuan said. “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. NaturalVue Multifocal 1 Day will continue to mine the study and share results with the industry and eye care practitioners (ECPs) around the world.”

Dr. Aragón
Dr. Aragón

Chief Executive Officer and Executive Director of VTI Juan Carlos Aragón, OD, added, “As we continue to glean new learnings from this extensive data set, it is evident that NaturalVue represents a powerful tool for ECPs to use to manage myopia. These results should provide confidence to both ECPs 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 2- and 3-year data when available.

To download a Fact Sheet summarizing the findings to date, click here.

Read more news from WO here.

RESOURCES

* Note: This reflects the 1-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 -0.75 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.

  1. 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.
  2. Brennan N, Toubouti Y, Cheng X et al. Efficacy in myopia control. Progress in Retinal and Eye Research 83 (2021) 100923
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