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Efficacy and safety of 0.01% atropine for prevention of childhood myopia in a 2-year randomized placebo-controlled study



Atropine eye drops prevent the progression of myopia, but their use has not been tested in the Japanese schoolchildren population. Here, we evaluate the efficacy and safety of 0.01% atropine eye drops for myopia control in Japanese children.

Study design

Multicenter (7 university hospitals), randomized, double-masked, placebo-controlled trial.


Participants were 171 Japanese schoolchildren aged 6 to 12 years, with progressive myopia, spherical equivalence (SE) of −1.00 to −6.00 diopters (D), and astigmatism of ≤1.5 D. They were randomized to receive either 0.01% atropine (n=85) or placebo (n=86) eye drops once nightly OU for 24 months. Primary and secondary efficacy endpoints were changes in SE and axial length (AL), respectively, from baseline to month 24.


Data from 168 subjects were analyzed. At month 24, compliance was similar in both groups (atropine: 83.3%; placebo: 85.7%). The least squares mean change in SE and AL from baseline were, respectively, −1.26 D (95% confidence interval [CI]: −1.35, −1.17) and 0.63 mm (0.59, 0.67) for atropine and −1.48 D (− 1.57, −1.39) and 0.77 mm (0.73, 0.81) for placebo. Inter-group differences were 0.22 D (95% CI: 0.09, 0.35; P < 0.001) for SE and − 0.14 mm (−0.20, −0.08; P < 0.001) for AL. Three patients experienced mild allergic conjunctivitis side effects, with no inter-group difference in incidence (atropine: 2.4%; 2/84 patients; placebo: 1.4%; 1/84 patients).


With good compliance, 0.01% atropine is effective and safe for preventing the progression of childhood myopia.

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The authors wish to thank Mr. John Bush and Mr. Takahiko Murata for editing the manuscript. This study was supported by Eye-Lens Pte., Ltd., Singapore. The sponsor had no role in the design or conduct of this research.

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Corresponding author

Correspondence to Shigeru Kinoshita.

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Conflicts of interest

O. Hieda, None; T. Hiraoka, None; T. Fujikado, None; S. Ishiko, None; S. Hasebe, None; H. Torii, Honorarium for lecturing (Santen, Otsuka, HOYA, Alcon, ROHTO), Remuneration (Tsubota Laboratory), Honorarium (MediProduce); H. Takahashi, None; Y. Nakamura, None; C. Sotozono, None; T. Oshika, None; T. Morimoto, None; K. Nishida, None; N. Nishikawa, None; Y.S. Song, None; T. Tokutake, None; Y. Nishi, None; Y. Shigeno, None; T. Kurihara, Grant (Tsubota Laboratory, Fuji Xerox, KIRIN, Kowa, Santen, SEED), Grant, Honorarium for lecturing (Novartis, ROHTO), Honorarium for lecturing (Bayer); K. Negishi, Grant, Honorarium for lecturing (Alcon, Universal View, Abbott, Kowa, Santen, Hitachi, Senju, TOMEY), Grant (Fuji Xerox, Bausch & Lomb), Grant, Honorarium for lecturing, Non-Financial support (HOYA), Consultant fee (NIDEK), Honorarium for lecturing (Otsuka, ZEISS, santec); K. Tsubota, Grant (Tsubota Laboratory, ROHTO), Tsubota Laboratory and the author own the patent for Myopia Prevention Article; M. Ono, None; T. Nakai, None; D. Tan, Consultant fee (Eye-Lens Pte); S. Tanaka, Consultant fee (Boehringer Ingelheim), Non-financial support (AstraZeneca, Taiho, Ono, JMDC, DeNA Life Science), Honorarium for lecturing (Amgen); S. Kinoshita, Grant, Honorarium for lecturing, Consulting (Santen, Otsuka), Honorarium for Lecturing, Consulting (Senju, Alcon), Honorarium for Lecturing (Kowa, Johnson & Johnson), Grant (HOYA, CorneaGen), Honorarium for Consulting (Novartis).

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Corresponding Author: Shigeru Kinoshita

Supplementary Information

Below is the link to the electronic supplementary material.


Online Resource 1 Analysis of the Change of Spherical Equivalent and Axial Length from at Enrollment using Mixed Models (DOCX 17 KB)


Online Resource 2 Primary Analysis of Spherical Equivalent and Axial Length using Mixed Models for Per Protocol Set (DOCX 19 KB)

Online Resource 3 Analysis of Corrected VA using Mixed Models for Full Analysis Set (DOCX 18 KB)

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Hieda, O., Hiraoka, T., Fujikado, T. et al. Efficacy and safety of 0.01% atropine for prevention of childhood myopia in a 2-year randomized placebo-controlled study. Jpn J Ophthalmol 65, 315–325 (2021).

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  • Myopia control
  • Muscarinic receptor
  • School children
  • Placebo
  • Eye drop