A Randomized, Placebo-Controlled Clinical Trial of Tacrolimus Ophthalmic Suspension 0.1% in Severe Allergic Conjunctivitis

Abstract

Aims: To examine the effi cacy of tacrolimus ophthalmic suspension 0.1% in treating severe allergic conjunctivitis. Methods: This was a multicenter, randomized, double-masked, placebo-controlled clinical trial. Fifty-six patients with severe allergic conjunctivitis in whom topical antiallergic agents and corticosteroids had been ineffective were randomized to tacrolimus or placebo treatment. Patients were treated either with tacrolimus or placebo twice-daily for 4 weeks. Severity of objective signs in palpebral and bulbar conjunctiva, limbus, and corneal involvement was assessed using 4 grades. Seven subjective symptoms were evaluated by visual analog scale (VAS) assessment. The primary effi cacy endpoint was change in the total score of objective signs at the end of treatment. The secondary effi cacy endpoints included change in the score for each objective sign and change in the VAS for each subjective symptom. Safety was assessed based on the severity and the incidence of adverse events. Results: Mean change from baseline in total score for objective signs was signifi cantly greater in the tacrolimus (−5.6 ± 5.1) than in the placebo group (−0.1 ± 4.5; P < 0.001). Tacrolimus signifi cantly improved giant papillae ( P = 0.001) and corneal involvement ( P = 0.005). Five subjective symptoms (itching, discharge, hyperemia, lacrimation, and foreign body sensation) were signifi cantly better in the tacrolimus than in the placebo group. The most frequent treatment-related adverse event in the tacrolimus group was mild ocular irritation upon topical instillation, which was well-tolerated. Conclusion: Tacrolimus ophthalmic suspension 0.1% is effective in treating severe allergic conjunctivitis.

Topical 0.005% tacrolimus eye drop for refractory vernal keratoconjunctivitis

“…Although resolved corneal shield ulcer after treatment with topical tacrolimus has been reported previously, 24 no case in our series had this form of corneal involvement. Improvement in corneal findings in our series was associated with improvement of BSCVA in 8 (44%) out of 18 eyes with initial BSCVA less than 20/20.…”

“…In some previous studies, topical tacrolimus has been used just for 4 weeks in VKC with no follow-up after cessation of the treatment. 22,24 In the study by Miyazaki et al, 23 treatment with topical tacrolimus was continued for 7 months. Although improvement of clinical findings has been reported after topical tacrolimus, there is paucity of data regarding the optimal duration of the treatment.…”

“…22,23 In a recent study, 0.1% ophthalmic suspension of tacrolimus has been used for treatment of AKC and VKC with only 4 weeks of follow-up. 24 However, the long-term effects of the treatment remain unknown.…”

Tacrolimus Ointment for Treatment of Vernal keratoconjunctivitis

“…Tacrolimus is an effective agent for the management of patients with AKC and VKC who are refractory to conventional medications, including topical cyclosporine [12][13][14][15][16][17][18]. In our study, topical tacrolimus achieved good results in the management of severe cyclosporine-resistant VKC.…”

“…Tacrolimus ointment is used widely for the treatment of atopic dermatitis. Topical tacrolimus (0.02-0.1%) has also been used to treat giant papillary conjunctivitis, atopic keratoconjunctivitis (AKC), and VKC [12][13][14][15][16][17][18] with good results. Furthermore, a tacrolimus 0.1% ophthalmic suspension has been used for the treatment of AKC and VKC with only 4 weeks of follow-up [18] The purpose of this study was to evaluate the long-term clinical outcomes of tacrolimus ointment as a treatment for refractory VKC.…”