Peer-reviewed article
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.
Korenfeld M, Hurcikova M, Tatsuoka K, Tomciková D, Cheetham J et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study tested whether atropine eye drops can slow the progression of myopia (nearsightedness) in children aged 3-14 years in Europe and the USA. Over 24 months, children receiving atropine showed slower myopia progression compared to those receiving placebo, with the effect being strongest in children whose myopia was worsening quickly. Both concentrations tested were safe and well tolerated, with photophobia (light sensitivity) being the most common side effect.
Key points
- Atropine sulfate 0.01% slowed myopia progression by 0.13 diopters per year compared to vehicle (p = 0.0003)
- Atropine sulfate 0.03% slowed myopia progression by 0.12 diopters per year compared to vehicle (p = 0.0009)
- In fast progressors (those losing 0.50 diopters or more per year), atropine 0.01% showed greater benefit (0.21 diopters difference) than atropine 0.03% (0.15 diopters difference)
- Photophobia occurred in 16.7% of vehicle group, 24.1% of atropine 0.01% group, and 30.4% of atropine 0.03% group
- Treatment discontinuation rates were similar across groups (18.6-19.7%)
Limitations
The study was conducted primarily in white populations in Europe and the USA, so results may not generalise to other ethnic groups or regions. The 24-month follow-up period does not show whether benefits persist or safety issues emerge over longer use.
Abstract
Introduction 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. Methods 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. Results 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 sulfate 0.01% and 0.11 D (p = 0.0397) for atropine sulfate 0.03%. TEAEs were similar across groups. Photophobia was the most common ocular event (16.7% vehicle, 24.1% atropine sulfate 0.01%, 30.4% atropine sulfate 0.03%). Treatment discontinuation was similar across groups (18.7% vehicle, 19.7% atropine sulfate 0.01%, 18.6% atropine sulfate 0.03%). Conclusion Atropine sulfate 0.01% and 0.03% effectively slowed myopia progression in children, with greatest efficacy in Fast Progressors Subgroup 1. Both concentrations were well tolerated with manageable side effects, supporting atropine sulfate as a treatment option for pediatric myopia. Clinical trial registration ClinicalTrials.gov identifier NCT03918915.