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

  • Clinical Investigation
  • Published:
Japanese Journal of Ophthalmology Aims and scope Submit manuscript

Abstract

Purpose

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.

Methods

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.

Results

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).

Conclusion

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

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Acknowledgements

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.

Author information

Authors and Affiliations

  1. Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan

    Osamu Hieda, Yo Nakamura & Chie Sotozono

  2. Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, Tusukuba, Ibaraki, Japan

    Takahiro Hiraoka & Tetsuro Oshika

  3. Graduate School of Frontier Biosciences, Osaka University, Suita, Osaka, Japan

    Takashi Fujikado

  4. Department of Ophthalmology, Asahikawa Medical University, Asahikawa, Hokkaido, Japan

    Satoshi Ishiko, Noriko Nishikawa & Young-Seok Song

  5. Department of Ophthalmology 2, Kawasaki Medical School, Kurashiki, Okayama, Japan

    Satoshi Hasebe

  6. Department of Ophthalmology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan

    Hidemasa Torii, Yasuyo Nishi, Yuta Shigeno, Toshihide Kurihara, Kazuno Negishi & Kazuo Tsubota

  7. Department of Ophthalmology, Nippon Medical School, Bunkyo-ku, Tokyo, Japan

    Hiroshi Takahashi & Masafumi Ono

  8. Department of Advanced Visual Neuroscience, Osaka University Graduate School of Medicine, Suita, Osaka, Japan

    Takeshi Morimoto

  9. Department of Ophthalmology, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan

    Kohji Nishida

  10. Department of Ophthalmology, Kawasaki Medical School General Medical Center, Okayama, Okayama, Japan

    Tomoki Tokutake

  11. Tsubota Laboratory, Inc, Shinjuku-ku, Tokyo, Japan

    Kazuo Tsubota

  12. Clinical Biostatistics Course, School of Public Health, Graduate School of Medicine, Kyoto University, Kyoto, Kyoto, Japan

    Tomoko Nakai & Shiro Tanaka

  13. Singapore National Eye Centre, Singapore, Singapore

    Donald Tan

  14. Department of Frontier Medical Science and Technology for Ophthalmology, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kamigyo-ku, Kyoto, Kyoto, 602-0841, Japan

    Shigeru Kinoshita

Authors
  1. Osamu Hieda
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  2. Takahiro Hiraoka
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  3. Takashi Fujikado
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  4. Satoshi Ishiko
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  5. Satoshi Hasebe
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  6. Hidemasa Torii
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  7. Hiroshi Takahashi
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  8. Yo Nakamura
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  9. Chie Sotozono
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  10. Tetsuro Oshika
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  11. Takeshi Morimoto
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  12. Kohji Nishida
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  13. Noriko Nishikawa
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  14. Young-Seok Song
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  15. Tomoki Tokutake
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  16. Yasuyo Nishi
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  17. Yuta Shigeno
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  18. Toshihide Kurihara
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  19. Kazuno Negishi
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  20. Kazuo Tsubota
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  21. Masafumi Ono
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  22. Tomoko Nakai
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  23. Donald Tan
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  24. Shiro Tanaka
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  25. Shigeru Kinoshita
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Consortia

the ATOM-J. Study Group

Corresponding author

Correspondence to Shigeru Kinoshita.

Ethics declarations

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.

10384_2021_822_MOESM1_ESM.docx

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

10384_2021_822_MOESM2_ESM.docx

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). https://doi.org/10.1007/s10384-021-00822-y

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  • DOI: https://doi.org/10.1007/s10384-021-00822-y

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