Visioneering Technologies, Inc. has released 1-year interim retrospective data from the PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial (PROTECT) during the American Academy of Optometry (AAOPT) annual meeting.
Let’s start with this product.
Designed for single, daily disposable use, NaturalVue Multifocal (MF) (etafilcon A), VTI’s flagship product, is an extended depth-of-focus (EDOF) contact lens with ADD power options up to +3.00 for managing both myopia and presbyopia.
The company’s proprietary Neurofocus Optics design creates the EDOF, allowing for multiple focal points—unlike traditional multifocal lenses, which only have two—along the visual axis and resulting in a wider range of clear vision.
Gotcha. Now PROTECT study.
The multi-center, randomized, double-masked clinical trial (NCT05159765) is a 3-year study assessing the use of the NaturalVue Multifocal 1 Day for myopia progression control in pediatric patients.
And the participants?
An estimated 144 patients (ages 7 to 13) were enrolled based on the following criteria:
- Spherical equivalent refractive error (SERE) between -0.75 and -5.00 D
- Astigmatism: ≤ -0.75 D
- Anisometropia: < 1.00 D
Of note, a modified PP (Per Protocol) analysis includes children between baseline ages 8 and <13 with refractive error between -0.75 and -4.00 D versus age-matched controls wearing spherical lenses.
See here for exclusion criteria.
How were patients assessed?
Participants were split into two groups to wear either:
- NaturalVue MF 1 Day (refractive correction)
- Placebo (single-vision optic, refractive correction)
Investigators hypothesized that contact lens wear during daytime hours might alter myopia progression.
And how was this measured?
A couple ways:
- Primary: change in refractive error relative to baseline, as determined by mean change in cycloplegic auto-refraction (D)
- Secondary: change in axial length (AL), as determined by mean change in AL (mm)
Both measurements were taken at baseline, 12, 24, and 36 months.
Now these findings.
VTI Chief Medical Officer and study chair investigator Ashley Tuan, OD, PhD, presented the preliminary 1-year data, reporting that NaturalVue MF lenses demonstrated safety and efficacy in slowing myopia progression.
To note, participating investigators originated from Canada, the United States, Hong Kong, and Singapore.
Give me some numbers.
Based on data from 93% of the study participants, the lenses’ average (standard deviation [SD]) treatment effect (for 1 year) illustrated:
- 0.41 D (69%) refractive error reduction vs control group
- 0.17 mm (59%) AL reduction vs control group
For NaturalVue MF wearers, the SD change found in comparison:
- 0.18 D (0.39) for refractive error
- 0.13 mm (0.12) for axial length
Any patient drop-outs reported?
Six patients so far have voluntarily discontinued—equating to a 4% drop-out rate.
So what does all this mean?
Per Dr. Tuan, these treatment effects are “consistent with those of the only treatment approved by the FDA for myopia progression control, which we view as a positive result.”
Plus, the data confirms two previous studies on NaturalVue MF’s efficacy:
- A 2022 retrospective, cohort analysis published in Clinical Ophthalmology on a 6-year follow-up period of pediatric patients fitted with NaturalVue MF,
- The result: average myopia progression slowed by 85% compared to baseline—a statistically significant reduction at all time points.
- An analysis from three independent retrospective studies, published in September 2023.
- The conclusion: NaturalVue MF use “effectively manages eye growth and refractive error among children in diverse settings over at least 2 years of follow-up.”
- Click here for our coverage.
- The conclusion: NaturalVue MF use “effectively manages eye growth and refractive error among children in diverse settings over at least 2 years of follow-up.”
So what’s next?
Interim analyses are planned for the 1-year and 2-year patient follow-ups, according to VTI, with the final results of the study and any regulatory uses after being based on the analysis of the complete 3-year data set.
Per Clinical Trials, the study is slated to conclude in Q3 2025.
The presentation, “Seeing is Believing: NaturalVue Multifocal 1-Year RCT Myopia Data Preview and Independent Real-World Retrospective Studies Data Comparison,” was presented during the American Academy of Optometry (AAOPT) annual meeting in New Orleans, Louisiana, October 11-14, 2023.