Visioneering Technologies' New Contact Lens Trial Shows Landmark Results in Slowing Children's Nearsightedness

Completed three-year PROTECT randomized controlled trial finds NaturalVue Multifocal 1 Day contact lens slowed myopia progression by 1.06 diopters and eye elongation by 0.58 mm at 36 months.1,2

Visioneering Technologies, Inc. (VTI), a medical device company that designs and markets specialty contact lenses, will announce completed three-year results from PROTECT, a prospective, double-masked, multinational randomized controlled trial evaluating the company's NaturalVue^® (etafilcon A) Multifocal 1 Day Contact Lens for slowing the progression of myopia, or nearsightedness, in children. Ashley Tuan, OD, MS, PhD, VTI's Chief Medical Officer, will present the full findings at the American Academy of Optometry's annual meeting in Anaheim.

Myopia develops when a child's eye grows too long, causing distant objects to appear blurry, and it typically worsens through childhood. Faster progression is associated with a higher lifelong risk of more serious eye conditions, including retinal detachment and myopic maculopathy, a leading cause of permanent vision loss. Slowing that progression, even modestly, is considered clinically meaningful.^3,4

Over three years, children who wore NaturalVue Multifocal 1 Day showed the following results compared with a virtual control group^1,2:

• 1.06 diopters less myopic progression (95% CI 0.86 to 1.25, p < 0.001)
• 0.58 millimeters less axial elongation (lengthening of the eye) (95% CI −0.66 to −0.49, p < 0.001)

The results cover both refractive error and axial length, the two primary measures^5,6 researchers use to track myopia progression and represent one of the largest treatment effects reported to date for a soft contact lens in a randomized controlled trial.

Randomized Controlled Evidence for an Established Lens Design

With the successful completion of the PROTECT clinical trial, NaturalVue Multifocal 1 Day is the first soft contact lens built on a catenary power curve design^7,8 to demonstrate more than 1.00 diopter less myopic progression than a control group over three years^1,2, according to the company.

“The PROTECT clinical trial adds important three-year double-masked, randomized controlled evidence to what we know about NaturalVue Multifocal 1 Day,” said Ashley Tuan, OD, MS, PhD. “What is especially meaningful is the breadth of the findings. We see a large refractive treatment effect together with significant slowing of axial elongation to the expected level for emmetropic children of these ages and ethnicities, providing a more complete picture of NaturalVue's performance in children with myopia.”

Why Researchers Say the Size of the Effect Matters

Published research on myopia control indicates that reducing progression by 1.00 diopter is associated with roughly a 40% lower likelihood of developing myopic maculopathy³ and about a 23% lower risk of retinal detachment⁴, independent of any single treatment.

“Every diopter matters, which is why the magnitude of the completed PROTECT clinical trial results is important,” said Brett O'Connor, OD, FAAO*, Smith Eye Associates, Ponte Vedra, FL. “NaturalVue Multifocal 1 Day demonstrated 1.06 D less myopic refractive progression versus control at three years, along with a 0.58 mm reduction in axial elongation versus control.^1,2 For eye care professionals managing pediatric progressive myopia, the amount of progression you can reduce matters for the long term.”

Meaningful Results for Myopic Children

In the PROTECT clinical trial, children wearing NaturalVue Multifocal 1 Day showed eye growth similar to non-myopic children over 36 months:^1,2

• 59% progressed ≤0.25 D per year on average, consistent with the threshold commonly used to define non-progressive myopia.⁹
• 55% had axial growth within the emmetropic benchmark of the study.^1,2
• Across all age groups studied, average axial growth trends stayed within published emmetropic growth ranges.¹⁰,¹¹

Company Perspective

“Correcting a child's myopia today is only part of the opportunity,” said Jeff Pruett, Chief Operating Officer of Visioneering Technologies. “The broader goal is managing how much myopia each child develops over time, to protect their vision for tomorrow. The completed PROTECT clinical trial gives eye care professionals more evidence to inform that decision, and more reason than ever to consider NaturalVue Multifocal 1 Day.”

The company said the completed trial gives eye care professionals a powerful evidence base to guide the long-term myopia-management decisions they make for children every day.

About the PROTECT Trial

PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial) is a three-year, prospective, double-masked, multinational randomized controlled trial evaluating the safety and effectiveness of the NaturalVue^® (etafilcon A) Multifocal 1 Day Contact Lens for slowing myopia progression. It was conducted at sites in the United States, Canada, Hong Kong and Singapore. Data were adjusted for age, sex, ethnicity, country, study site and baseline refractive value. The per-protocol cohort included 102 children ages 7 up to 13 with baseline refraction of −0.75 to −5.00 diopters (p < 0.001). For more information on the PROTECT trial details, contact the Visioneering Technologies, Inc. media contact (contact information listed below).

About Visioneering Technologies

Visioneering Technologies, Inc. is an eye care company focused on advanced optical design. Its flagship product, the NaturalVue^® (etafilcon A) Multifocal 1 Day Contact Lens, uses a proprietary extended-depth-of-focus design intended to support vision correction for myopia, presbyopia and astigmatism. The company is headquartered in Alpharetta, Georgia. For more information, visit vtivision.com.

This release may describe uses for NaturalVue Multifocal 1 Day, including myopia progression control, that the U.S. Food and Drug Administration has not approved for use in the United States. That information is provided for educational purposes only.

Notes to Editors / References

1. Data on file. PROTECT 3-Year Results, 2026. Data adjusted for key variables, including age, sex, ethnicity, country, study site, and baseline value. Per-protocol cohort, baseline age 7–<13 years, −0.75 D to −5.00 D, n = 102 (p < 0.001). All data vs. virtual control group. 36-month single-vision contact lens control values were derived from several complementary analyses, including SVCL projections (24-month SVCL patient data projected to 36 months) and a DyNaSynth™ virtual control matched to the SVCL group's baseline characteristics. The modeled control trajectories showed a high degree of concordance with published virtual control models.
2. Tuan KA, Novak S, Chan J, Dillehay SM; PROTECT Study Group. PROTECT Completed 3-Year Study Results: A Catenary-Curve Multifocal Contact Lens Reduces Pediatric Myopia Progression and Mitigates Common Risk Factors. Poster presented at: American Academy of Optometry Annual Meeting; September 30–October 3, 2026; Anaheim, California.
3. Bullimore MA, Brennan NA. Myopia Control: Why Each Diopter Matters. Optom Vis Sci. 2019;96(6):463–465. doi:10.1097/OPX.0000000000001367.
4. Bullimore MA, Ritchey ER, Shah S, et al. The Risks and Benefits of Myopia Control. Ophthalmology. 2021;128(11):1561–1579. doi:10.1016/j.ophtha.2021.04.032.
5. Walline JJ, Robboy MW, Hilmantel G, et al. Food and Drug Administration, American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometric Association, American Society of Cataract and Refractive Surgery, and Contact Lens Association of Ophthalmologists Co-Sponsored Workshop: Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices. Eye Contact Lens. 2018;44(4):205–211. doi:10.1097/ICL.0000000000000511.
6. Wolffsohn JS, Kollbaum PS, Berntsen DA, et al. IMI – Clinical Myopia Control Trials and Instrumentation Report. Invest Ophthalmol Vis Sci. 2019;60(3):M132–M160. doi:10.1167/iovs.18-25955.
7. Irving EL, Yakobchuk-Stanger C. Myopia progression control lens reverses induced myopia in chicks. Ophthalmic Physiol Opt. 2017;37(5):576–584. doi:10.1111/opo.12400.
8. Patents Awarded – MULTIFOCAL OPHTHALMIC LENS WITH INDUCED APERTURE. See https://vtivision.com/about/patents/ for patent numbers.
9. Chen J, Liu S, Zhu Z, et al. Axial length changes in progressive and non-progressive myopic children in China. Graefes Arch Clin Exp Ophthalmol. 2023;261(5):1493–1501. doi:10.1007/s00417-022-05901-5.
10. Naduvilath T, He X, Saunders K, et al. Age, gender and regional/ethnic variations in emmetropic axial growth rate. Ophthalmic Physiol Opt. 2025;45(6):1485–1495. doi:10.1111/opo.13545.
11. Zadnik K, Mutti DO, Mitchell GL, Jones LA, Burr D, Moeschberger ML. Normal eye growth in emmetropic schoolchildren. Optom Vis Sci. 2004;81(11):819–828. doi:10.1097/01.opx.0000145028.53923.67.

*Dr. O'Connor is a paid consultant of Visioneering Technologies, Inc.

SOURCE Visioneering Technologies, Inc.

VTI-RCT-PR13 r1

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