Therapeutic effects of 0.1% tacrolimus eye drops for refractory allergic ocular diseases with proliferative lesion or corneal involvement.
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.


BACKGROUND
UMIN 000008640.
Department of Ophthalmology, Kochi Medical School, Kochi, Japan.
Atsuki
A
Fukushima
Department of Ophthalmology, Ehime University School of Medicine, Ehime, Japan.
Yuichi
Y
Ohashi
Department of Ophthalmology, Juntendo University School of Medicine, Tokyo, Japan.
Nobuyuki
N
Ebihara
Department of Ophthalmology, Fukuoka University School of Medicine, Fukuoka, Japan.
Eiichi
E
Uchio
Okamoto Eye Clinic, Ehime, Japan.
Shigeki
S
Okamoto
Kumagai Eye Clinic, Yamaguchi, Japan.
Naoki
N
Kumagai
Department of Ophthalmology, Division of Visual Sciences, Nihon University School of Medicine, Tokyo, Japan.
Jun
J
Shoji
Department of Ophthalmology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.
Etsuko
E
Takamura
Nakagawa Eye Clinic, Osaka, Japan.
Yayoi
Y
Nakagawa
Department of Ophthalmology and Visual Science, Hokkaido University Graduate School of Medicine, Hokkaido, Japan.
Kenichi
K
Namba
Department of Ophthalmology, Tsurumi University Dental Hospital, Kanagawa, Japan.
Hiroshi
H
Fujishima
Department of Ophthalmology, Tottori University School of Medicine, Tottori, Japan.
Dai
D
Miyazaki
D000293:Adolescent; D000328:Adult; D002648:Child; D003233:Conjunctivitis, Allergic / Q000150:complications / Q000188:drug therapy*; D003316:Corneal Diseases / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D009883:Ophthalmic Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
D007166:Immunosuppressive Agents; D009883:Ophthalmic Solutions; D016559:Tacrolimus
Conjunctiva; Drugs; Immunology; Inflammation; Treatment Medical