Efficacy and Safety of Low-Concentration Atropine in Slowing Myopia Progression in Children in Japan: The Randomized, Double-Blind Phase II/III ORANGE Study.

ABSTRACT:

Purpose

To evaluate the efficacy and safety of low-concentration atropine ophthalmic solution for slowing disease progression in children with myopia and assessing rebound phenomenon after treatment cessation.

Design

A randomized, double-masked, placebo-controlled, phase II/III clinical trial in Japan.

Subjects

Children (n = 299) aged 5-15 years with cycloplegic objective spherical equivalent (SE) -1.0 to -6.0 diopters (D) in both eyes.

Methods

Subjects were randomized to atropine 0.01%, 0.025%, or placebo (1 drop once daily before bedtime in both eyes) for 24 months before receiving atropine 0.01%, 0.025%, or placebo for a further 12 months.

Main outcome measures

The primary endpoint was mean SE change from baseline at month 24; axial length (AL) change

SUBMITTER: Ohno-Matsui K 

PROVIDER: S-EPMC12651634 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature