Q&A: Evaluating 24-month outcomes with Abiliti 1-Day in pediatric myopia control

Myopia progression in children has emerged as one of the most pressing concerns in modern ophthalmology, with prevalence rising sharply across East Asian populations and increasingly worldwide. For retinal specialists and comprehensive ophthalmologists alike, the window for meaningful intervention is narrow—and the demand for effective, patient-friendly treatment options has never been greater. This Q&A examines 24-month real-world outcomes for Abiliti 1-Day (senofilcon A), a daily disposable soft contact lens designed to slow axial elongation and myopia progression in children aged 7 to 12.

The findings presented here draw from a prospective, single-arm clinical study conducted at Aier Eye Hospital within the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, China—a unique regulatory environment that allows evaluation of devices approved internationally but not yet in mainland China. Results were compared against an external real-world control cohort of single-vision spectacle wearers matched on age, refractive error, and axial length.

Editor’s note: This interview was conducted via email and was lightly edited for style and clarity.

Why was a single-arm design with a real-world control chosen over a traditional randomized controlled trial?

Alex Nixon, OD: The study was conducted in the Boao Lecheng International Medical Tourism Pilot Zone, a unique real-world clinical setting in China where medical devices approved overseas but not yet approved in mainland China may be introduced to patients. In this setting, the primary objective was to evaluate Abiliti 1-Day as it was being used in practice, which made a traditional parallel-group randomized controlled trial less aligned with the clinical introduction pathway. A prospective single-arm design was chosen to collect real-world safety and performance data while allowing all enrolled children to receive the lens.

To provide clinical context for the observed outcomes, the investigators compared results from the treated cohort with an external real-world control derived from EMR data for demographically similar children wearing single-vision spectacles and meeting predefined eligibility criteria. Although this design does not provide the same level of causal inference as a randomized controlled trial, the study incorporated key elements of rigorous clinical research, including prespecified eligibility criteria, scheduled follow-up, standardized outcome measurements, and investigator training, to support a scientifically reliable interpretation of the safety and performance findings.

The A1D group showed roughly 54% less axial elongation than controls. How clinically significant is that difference?

Nixon: At 24 months, children wearing the Abiliti 1‑Day lenses showed mean (SD) myopia progression of −0.56 D (0.57) and axial elongation of 0.23 mm (0.26), approximately half of the progression observed in the real-world control group wearing single-vision spectacles (−1.16 D (0.87); 0.50 mm (0.23)). As noted in the prior question, a global randomized controlled trial would be preferred to draw generalized conclusions about the treatment effect, but the results are on par with those for the more effective treatments in similar, single site studies.

The clinical relevance of these findings is further supported by the overall lens performance. Children were able to wear the lenses consistently, averaging 6.8 days per week and 14.0 hours per day at 24 months, with no contact lens-related serious or significant adverse events reported. Visual acuity outcomes were also strong, with average monocular and binocular distance visual acuity better than 20/20. Taken together, these findings suggest that Abiliti™ 1-Day provided meaningful myopia-control benefit while also demonstrating good wearability, visual performance, and safety in this pediatric population.

How confident are you that EMR-derived, spectacle-wearing patients represent a valid control group for this comparison?

Nixon: We believe the EMR-derived spectacle-wearing cohort provides a reasonable real-world comparator because the control cohort was drawn from the same clinical network, restricted to children who met predefined eligibility criteria similar to those used in the prospective study, and evaluated over the same 24-month time horizon using consistent measurements of refraction and axial length. At baseline, the groups were similar in mean age, refractive error, axial length, and percentage of female subjects. However, because this was not a randomized comparison, we cannot completely rule out remaining differences between groups or inconsistencies in how data were collected. We view the comparison as supportive and contextual rather than confirmatory, while recognizing that a randomized controlled trial would remain the preferred design for causal inference.

How generalized are these findings to myopic children outside of Chinese pediatric populations?

Nixon: The findings are most directly applicable to Chinese children similar to those enrolled in this study. However, the optical treatment principle of myopia-control soft contact lenses is not population-specific, and treatment effects for this class of intervention have been reported across diverse study populations. In a shorter-term, international, multi-site randomized controlled trial that included this lens design, there was no evidence that treatment efficacy differed by age or race (Cheng et al., 2022). Additional prospective studies in more diverse populations and practice settings would help further establish generalizability.

Children averaged 14 hours of daily wear. Is that compliance level realistic in broader clinical practice?

Nixon: Although the primary focus of this study was myopia control, the Abiliti 1-Day also provided everyday vision correction. Peer-reviewed studies by Walline and colleagues have shown that contact lens wear in children can improve vision-related quality of life, including satisfaction with correction, appearance, participation in activities, and aspects of self-perception such as athletic competence and social acceptance. In addition, unlike spectacles, contact lenses are less easily removed during the day for specific activities, which may support more consistent treatment exposure. In clinical practice, wear times above the minimum recommended threshold of 8 hours per day and 5 days per week would generally be expected, although actual wear time may vary across children depending on lifestyle, preferences, etc.

No serious adverse events occurred. What monitoring protocols would you recommend when fitting children as young as 7?

Nixon: Overall, the peer-reviewed literature suggests that soft contact lens wear in children appears safe, with low rates of serious corneal adverse events. A colleague, Augustine Nti, presented results at ARVO for a safety related analysis that concluded microbial keratitis rates in children are comparable to those in adults, while corneal infiltrative event rates may be lower in children, particularly in those 12 years of age or younger, which is the primary target age range for myopia control.

To address the question about monitoring protocols, when fitting children as young as 7 years old I would recommend a structured approach that addresses contact lens safety, lens wear compliance, and myopia control efficacy. In practice, this would involve closer early follow-up after fitting to confirm successful insertion and removal, appropriate lens fit and comfort, visual acuity, ocular surface health, and family understanding of hygiene and replacement instructions. Thereafter, regular follow-up should continue to monitor ocular health, lens wearing patterns, and myopia progression. The exact schedule should be individualized based on the child’s maturity, lens-wearing success, myopia progression, and any safety concerns.

Where does Abiliti 1-Day fit within the broader myopia management algorithm alongside orthokeratology and atropine therapy?

Nixon: The availability of a range of effective myopia control modalities enables the clinician to consider factors beyond efficacy when prescribing for their patients. Ultimately, treatment success depends not only on the inherent effectiveness of a treatment but also on whether the child can use the therapy consistently, since adherence is a key determinant of real-world benefit. As a result, the most appropriate modality is often the one that best fits the child’s motivation, lifestyle, and family preferences.

In that context, Abiliti 1-Day may be particularly appealing for children and families who prefer a contact lens option with no need for overnight lens wear. Because a fresh lens is used each day, there is no need for cleaning, disinfection, or storage. Compared with spectacles, contact lenses can offer greater freedom for sports and other activities and are less easily removed during the day, which may support more consistent treatment exposure. Daily disposable soft contact lenses also provide a nonpharmacologic option that avoids both eyedrops and the overnight wear required with orthokeratology, giving clinicians and families another first-line modality that may align well with individual preferences.

Disclaimer: ACUVUE Abiliti is not approved for either the US or China.

Alex Mixon, OD, MS, FAAO

Dr. Nixon is a graduate of The Ohio State University College of Optometry. He completed a Fellowship in Cornea and Contact Lenses at OSU, where he conducted research regarding scleral lenses, higher-order aberration correction with contact lenses, contact lens fit assessment with optical coherence tomography, and myopia control. He was a Clinical Assistant Professor at OSU for several years, where he taught general clinical and contact lens practice and also conducted myopia control soft contact lens research.

He joined Johnson and Johnson Vision in 2019 and as a part of Clinical Science group, his team’s mission is to design and conduct rigorous research to help JJV identify evidence-based insights that shape the contact lens products of the future and define their benefits. He has led research related to myopia progression in children, contact lens clinical trials, and translational vision science studies. Dr. Nixon is also the Clinical Lead for the development of patient-reported outcomes questionnaires, which help quantify the clinical performance and benefits of our medical devices or treatments.