EssilorLuxottica has reported six-month interim results from an ongoing randomized, double-masked clinical trial evaluating Essilor Stellest 2.0 spectacle lenses for myopia management in children in China.
At six months, Stellest 2.0 lenses produced a treatment effect of 0.51 D for myopia progression and 0.21 mm for axial elongation, compared with single-vision spectacle lenses. The ongoing two-year study includes 62 children in the Stellest 2.0 group and 58 wearing single-vision lenses for the principal efficacy comparison.
The results were presented during an EssilorLuxottica satellite symposium at the World Society of Pediatric Ophthalmology and Strabismus (WSPOS) Subspecialty Day, held alongside the European Society of Cataract and Refractive Surgeons (ESCRS) Congress in London.
According to the company, the magnitude of the six-month treatment effect is similar to that reported after 12 months in an earlier trial of first-generation Stellest lenses. However, the comparison is indirect: the studies involved different populations, age groups, locations, designs and follow-up periods, and no formal statistical comparison between the two studies was performed. The earlier trial reported treatment effects of 0.53 D for spherical equivalent refraction and 0.23 mm for axial length at 12 months.
Professor Yang Xiao, Principal Investigator at Zhongshan Ophthalmic Center, Sun Yat-sen University, said the interim findings were encouraging, particularly given the relatively limited refractive progression observed during the first six months. He also highlighted the consistency of the refractive and axial-length findings.
Compliance was high in both treatment groups, with more than 90 percent of children reported to have worn their spectacles for more than 12 hours per day, seven days a week. EssilorLuxottica also reported that 98 percent of participants had fully adapted to the lenses within one week, with adaptation and wearer comfort described as comparable to single-vision lenses.
The China trial remains ongoing, and participants will continue to be followed to assess longer-term efficacy and safety. The prespecified one-year analysis will serve as the study’s primary efficacy endpoint, making the forthcoming results important for determining whether the early treatment effect is sustained.
The interim findings add to earlier clinical evidence for Stellest 2.0. A randomized contralateral crossover study conducted in Singapore and published in Translational Vision Science & Technology in 2025 also evaluated the higher-power, more aspherical lenslet design used in Stellest 2.0. EssilorLuxottica says the China findings are consistent with the clinical performance observed in that study.
The six-month data provide an early indication of the potential performance of the second-generation lens, while the planned one-year and longer-term analyses will provide a fuller picture of its efficacy and safety.
