Use of tacrolimus 0.1% eye drops is highly effective in treating refractory allergic conjunctivitis, according to a study published in the April 2 online British Journal of Ophthalmology.
The prospective observational study evaluated the eyes of 1,436 patients with refractory allergic conjunctivitis who did not respond favorably to prior treatment with conventional allergy drugs, topical steroids and/or topical cyclosporine.
During the trial, tacrolimus 0.1% drops were administered twice daily to each patient. The researchers rated 10 clinical signs (palpebral conjunctiva hyperemia, diffuse edema, follicles, papillae, giant papillae, bulbar conjunctiva hyperemia, bullous edema, limbal trantas’ dot, swelling and corneal epithelial signs) and six clinical symptoms (itching, discharge, lacrimation, photophobia, foreign body sensation and eye pain) on a four-grade scale (0=none, 1=mild, 2=moderate and 3=severe).
Patients were graded at baseline, one month, two months, three months and six months. The total score of both the 10 clinical signs (range 0-30) and six clinical symptoms (range 0-18) decreased significantly from baseline to the one-month evaluation (p<0.001), indicating the agent’s ability to provide rapid relief.
At baseline, the mean total score of clinical signs was 15.3; at final observation, the mean total score decreased to 5.9. The mean total score of clinical symptoms decreased from 8.1 at baseline to 1.8 at final observation. Additionally, both giant papillae and corneal lesions were reduced significantly (p<0.001) following use of tacrolimus 0.1%.
Prior to initiating tacrolimus therapy, 239 patients were treated with cyclosporine 0.1% eye drops for at least one month; these patients exhibited giant papillae or corneal epithelial disorder scores greater than two at initiation of treatment.
Following one month of tacrolimus use their clinical signs score decreased from 16.8 to 6.7, and their clinical symptoms score decreased from 9.1 to 1.9.
The researchers noted adverse reactions in 117 patients, with the only major reaction being a burning sensation (45 cases).
Additionally, two cases of bacterial keratitis, two cases of herpetic keratitis and one case of bacterial corneal ulceration were observed. Atopic dermatitis or asthma was noted as an underlying condition in these cases.
Initially developed as an immunosuppressant for use following organ transplantation, tacrolimus is now used clinically for multiple immune-mediated conditions. The researchers suggest that the use of topical tacrolimus is both safe and effective in treating patients with severe allergic conjunctivitis.
1. Fukushima A, et al. Therapeutic effects of 0.1% tacrolimus eye drops for refractory allergic ocular diseases with proliferative lesion or corneal involvement. Br J Ophthalmol. 2014 Apr 2. [Epub ahead of print]