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

Abstract

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.

• Authors: Atsuki Fukushima, Yuichi Ohashi, Nobuyuki Ebihara, Eiichi Uchio, Shigeki Okamoto, Naoki Kumagai, Jun Shoji, Etsuko Takamura, Yayoi Nakagawa, Kenichi Namba, Hiroshi Fujishima, Dai Miyazaki
• Journal: The British journal of ophthalmology (Br J Ophthalmol) Vol. 98 Issue 8 Pg. 1023-7 (Aug 2014) ISSN: 1468-2079 [Electronic] England
• PMID: 24695688 (Publication Type: Journal Article, Observational Study, Research Support, Non-U.S. Gov't)
• Copyright: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Chemical References

• Immunosuppressive Agents
• Ophthalmic Solutions
• Tacrolimus

Topics

• Adolescent
• Adult
• Child
• Conjunctivitis, Allergic (complications, drug therapy)
• Corneal Diseases (drug therapy, etiology)
• Female
• Humans
• Immunosuppressive Agents (administration & dosage, adverse effects)
• Male
• Ophthalmic Solutions (administration & dosage, adverse effects)
• Prospective Studies
• Tacrolimus (administration & dosage, adverse effects)
• Young Adult