CooperVision has completed enrollment in its global post-approval clinical studies (PAS) for MiSight 1 day, marking a milestone in the generation of real-world evidence for pediatric myopia control.

The US and China-based studies collectively represent what CooperVision says is the longest international clinical evidence program ever undertaken for soft contact lens-based myopia control intervention in children.1-3 The initiative includes randomized controlled efficacy trials alongside large-scale safety registries designed to evaluate long-term outcomes in real-world clinical settings.1,4-8

The combined PAS programs span more than 100 clinical sites and include over 3,000 participating children.9 According to the company, the findings will build upon an already extensive body of international clinical research surrounding MiSight 1 day, which has been widely published and cited throughout the ophthalmology and optometry communities.1, 4-8

Participants enrolled in the studies represent diverse pediatric populations across the United States and China, providing data intended to support broader global applications in myopia management. Final study results are expected to be released on a rolling basis between 2027 and 2030.

“As clinicians, we all want long-term, real-world data that mirrors how myopia control is actually practiced,” said Jennifer Palombi, OD, FAAO, Director, Professional Affairs, Americas, CooperVision. “Completing enrollment in these post-approval studies is an important step forward for our category. MiSight 1 day was built on a strong foundation of clinical evidence, and this next phase will add meaningful insights that can help eye care professionals (ECPs) feel even more confident when managing pediatric myopia and guiding families through long-term care decisions.”

In conjunction with the enrollment milestone, CooperVision also released a new report titled "Progress in Focus: The Global Impact of MiSight 1 day." The publication compiles the expanding body of evidence surrounding the product and traces the evolution of the MiSight 1 day platform.

References:

  1. Chamberlain P et al. A 3-year Randomized Clinical Trial of MiSight® Lenses for Myopia Control. Optom Vis Sci. 2019; 96(8): 556-567. 
  2. Chamberlain P, et al. Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial. Optom Vis Sci. 2022 Mar 1;99(3):204-212. 
  3. Chamberlain P, et al. Myopia Progression in Children on cessation of Dual-Focus contact lens wear: MiSight 1 day 7-year findings. Optom Vis Sci 2021;98:E-abstract 210049.
  4. CVI data on file, 2022. 
  5. Chamberlain, Arumugam, Jones, et al. Myopia Progression in Children wearing Dual-Focus Contact Lenses: 6-year findings. Optom Vis Sci 2020;97(E-abstract):200038]
  6. Chamberlain, Arumugam, et al. Myopia progression cessation of Dual-Focus contact lens wear: MiSight 1 day 7 year findings. Optom Vis Sci 2021;98:E-abstract 210049.]
  7. Woods J et al. Ocular health of children wearing daily disposable contact lenses over a 6-year period. CLAE 2021 Aug;44(4):101391.
  8. Sulley A et al. Experience and subjective responses for children switched from single vision to dual focus myopia control daily disposable contact lenses. BCLA paper presentation 2021.
  9. CVI data on file, 2026.
  10. Holden BA, Fricke TR, Wilson DA, et al. Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology. 2016;123(5):1036-1042.