STudy of Atropine to Reduce (STAR) Myopia Progression in Children: 24-Month Results of a Randomized, Double-Masked, Vehicle-Controlled Trial of Atropine Sulfate 0.01% and 0.03%

作者：M. Korenfeld, Maria Hurcikova, K. Tatsuoka, D. Tomciková, J. Cheetham, Marek Kačerík · 发表于：Ophthalmology and Therapy · 年份：2026 · DOI：10.1007/s40123-026-01341-0 · 被引用次数：5 · 研究领域：Medicine

Pediatric myopia is rising globally, with high myopia associated with sight-threatening complications later in life. Low-dose atropine has been shown to slow myopia progression, with most studies conducted in Asian populations using compounded formulations. We evaluated the efficacy and safety of atropine sulfate ophthalmic solution at two concentrations for slowing myopia progression in a predominantly white population. STAR was a randomized, double-masked, vehicle-controlled, phase 3 clinical study conducted in Europe and the USA. Children (N = 847) aged 3–14 years with myopia between − 0.50 and − 6.00 diopters (D) were dosed after 1:1:1 randomization to vehicle, atropine sulfate 0.01% or 0.03% once daily before bedtime for 48 months. The primary endpoint was mean annual progression rate (APR) of myopia, measured by cycloplegic autorefraction, through month 24. Mean APR at 24 months was − 0.44 D/year (vehicle), − 0.31 D/year (atropine sulfate 0.01%), and − 0.32 D/year (atropine sulfate 0.03%), with differences versus vehicle of 0.13 D (95% CI 0.06–0.20; p = 0.0003) and 0.12 D (95% CI 0.05–0.19; p = 0.0009), respectively. In Fast Progressor Subgroup 1 (progression − 0.50 D/year or worse at baseline), differences versus vehicle were 0.21 D (p < 0.0001) for atropine sulfate 0.01% and 0.15 D (p = 0.0023) for atropine sulfate 0.03%. In Fast Progressor Subgroup 2 (progression − 0.75 D/year or worse at baseline), differences versus vehicle were 0.19 D (p = 0.0008) for atropine sul...