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Tuesday / June 25.
HomeminewsNew VTI PROTECT Data Presented at ARVO

New VTI PROTECT Data Presented at ARVO

New data points, revealed at the Association for Research in Vision and Ophthalmology (ARVO) meeting, further support that NaturalVue Multifocal 1 Day Contact Lenses (NVMF), may effectively manage eye growth and refractive error change among children under diverse clinical settings and populations.

Visioneering Technologies producer of the NVMF, continued its release of the one-year prospective data of its ongoing multi-centre, randomised, double-masked, controlled trial (RCT) at the annual meeting in May.

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. The three-year study involves 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 focussed on details of axial length and wearing time. Dr Tuan also summarised data released earlier in the year on refractive error change and reduction. The poster entitled, ‘A randomised 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 (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.

Compliance is believed to be essential for myopia control success and is influenced by the quality of vision and comfort.1 In this study, children on average wore NaturalVue for 11-12 hours per day, which VTI said is indicative that the lens provides excellent vision and comfort and a positive quality of life experience, contributing to the positive results seen thus far in the PROTECT study.

58% of patients wearing NaturalVue had axial growth similar to age-matched emmetropic children

Results at a Glance

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 ~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 three-year results.2

VTI said the PROTECT study data will continue to be reviewed and analysed 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. NaturalVue Multifocal 1 Day will continue to mine the study and share results with the industry and eye care practitioners around the world.”

Chief Executive Officer and Executive Director of VTI, Dr Juan Carlos Aragón, added, “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. 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.”

References

  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