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Therapeutic effects of 0.1% tacrolimus eye drops for refractory allergic ocular diseases with proliferative lesion or corneal involvement
  1. Atsuki Fukushima1,
  2. Yuichi Ohashi2,
  3. Nobuyuki Ebihara3,
  4. Eiichi Uchio4,
  5. Shigeki Okamoto5,
  6. Naoki Kumagai6,
  7. Jun Shoji7,
  8. Etsuko Takamura8,
  9. Yayoi Nakagawa9,
  10. Kenichi Namba10,
  11. Hiroshi Fujishima11,
  12. Dai Miyazaki12
  1. 1Department of Ophthalmology, Kochi Medical School, Kochi, Japan
  2. 2Department of Ophthalmology, Ehime University School of Medicine, Ehime, Japan
  3. 3Department of Ophthalmology, Juntendo University School of Medicine, Tokyo, Japan
  4. 4Department of Ophthalmology, Fukuoka University School of Medicine, Fukuoka, Japan
  5. 5Okamoto Eye Clinic, Ehime, Japan
  6. 6Kumagai Eye Clinic, Yamaguchi, Japan
  7. 7Department of Ophthalmology, Division of Visual Sciences, Nihon University School of Medicine, Tokyo, Japan
  8. 8Department of Ophthalmology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan
  9. 9Nakagawa Eye Clinic, Osaka, Japan
  10. 10Department of Ophthalmology and Visual Science, Hokkaido University Graduate School of Medicine, Hokkaido, Japan
  11. 11Department of Ophthalmology, Tsurumi University Dental Hospital, Kanagawa, Japan
  12. 12Department of Ophthalmology, Tottori University School of Medicine, Tottori, Japan
  1. Correspondence to Dr Atsuki Fukushima, Department of Ophthalmology, Kochi Medical School, Oko-cho Kohasu, Nankoku-shi, Kochi 783-8505, Japan; fukusima{at}


Background The objective of this study was to investigate the efficacy of topical 0.1% tacrolimus in treating refractory allergic conjunctivitis with proliferative lesions and/or corneal involvement.

Methods This prospective observational study included 1436 patients with refractory allergic conjunctivitis whose condition had responded poorly to conventional antiallergic drugs and/or topical steroids and/or topical cyclosporine. All patients received tacrolimus eye drops twice daily during the study period. Ten clinical signs and six clinical symptoms were rated on a four-grade scale. The primary endpoint was the change from baseline in total clinical signs and symptoms score at the last observation or following 6 months of treatment.

Results Total signs and symptoms score significantly decreased after 1 month of treatment (p<0.001). Giant papillae and corneal lesions were also reduced by tacrolimus eye drop use (p<0.001). The drug proved effective in patients whose condition did not respond well to topical cyclosporine therapy. About 50% of all patients using topical steroids were weaned. The most common adverse reaction was a transient burning sensation (3.20%).

Conclusions Tacrolimus eye drops are highly effective in treating refractory allergic conjunctivitis with proliferative lesions and/or corneal involvement, and may reduce or replace topical steroid use.

Trial registration number UMIN 000008640.

  • Conjunctiva
  • Drugs
  • Immunology
  • Inflammation
  • Treatment Medical

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