The latest encouraging data from PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial), an ongoing randomised, double-masked, controlled clinical trial, solidify NaturalVue as “a key tool for eye care practitioners managing myopia”, according to Dr Juan Carlos Aragón, CEO and Executive Director of Visioneering Technologies (VTI), manufacturer of NaturalVue (etafilcon A) Multifocal 1 Day contact lenses.
The latest data, presented by Dr Ashley Tuan, Chief Medical Officer at VTI, at both the International Myopia Conference and Vision By Design, highlights findings from an adjusted data analysis, complementing the previously shared unadjusted data. The poster, co-authored with Dr Sally Dillehay, was titled, “Optical Defocus to Influence the Progression of Myopia and Eye Growth Shows Dosage-Dependency in Children”, also explored the treatment effect based on pupil size.
These results further affirm our belief in the power of NaturalVue Multifocal to effectively manage myopia in children
Adjusted and Unadjusted Data Analyses
After equalising other variables that also impact myopia progression (age, sex, site and pupil size), the adjusted outcome value could better represent the true effect of the treatment. The analysis revealed outstanding outcomes for NaturalVue Multifocal, with an adjusted 89% (0.48 D) reduction in refractive error progression vs. control, compared to 71% (0.41 D) in the unadjusted analysis. Axial elongation showed a reduction of 0.17 mm (58%) vs. control, consistent with the 61% (0.17 mm) from unadjusted data. The adjusted analysis controls for external factors that may affect myopic progression, offering a more precise understanding of the treatment’s impact.
Treatment Effect and Pupil Size
Children in the study experienced positive treatment effects with NaturalVue Multifocal, regardless of their pupil sizes. However, the larger the pupil size, the greater the observed treatment effect. For refractive error, this reduction reflects ≤ 0.25 D myopic progression, considered to be clinically insignificant. Adjusted mean myopia magnitude was not different from baseline. With axial length the change is representative of near emmetropes. The study highlighted that even in children with smaller pupil sizes (those who spend considerable time outdoors), NaturalVue Multifocal provided continuous treatment, underscoring the importance of consistent wear for optimal results.
Previously Reported Key Findings from 1-Year Data:
• 58% of patients had physiological axial length growth similar to age-matched emmetropic children.
• Average daily wear time with NaturalVue Multifocal was 11-12 hours, matching control group usage and exceeding the study protocol (10 hours/day, six days/week).
• These prolonged wearing times, paired with low dropout rates (4%), suggest excellent vision and comfort, key contributors to treatment compliance.
Looking Ahead
Early findings from the one-year data align with predictions for longer-term outcomes, with three-year data expected to reinforce these results. The ongoing PROTECT trial will continue to analyse and share data as it becomes available. Combined with previously published six-year data and analyses from three independent studies, these findings support the continued study of NaturalVue Multifocal’s effectiveness in slowing myopia progression across diverse patient populations and clinical settings.
Dr Ashley Tuan, Chief Medical Officer of VTI, remarked: “Regardless of pupil size, all children in the study experienced a meaningful treatment effect with NaturalVue Multifocal. These results further affirm our belief in the power of NaturalVue Multifocal to effectively manage myopia in children.”
Dr Juan Carlos Aragón, CEO and Executive Director of VTI, added, “The comprehensive data set from the PROTECT study solidifies NaturalVue as a key tool for eye care practitioners managing myopia. The robust results provide assurance to both practitioners and parents that NaturalVue offers excellent vision correction while helping to manage myopia.”
VTI plans to release two-year and three-year data as it becomes available, offering further insights into the long-term efficacy of NaturalVue Multifocal lenses for myopia control.
Download a Fact Sheet summarising the findings to date here.