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Safety and Efficacy of Topical 0.1% And 0.05% Cyclosporine A in an Aqueous Solution in Steroid-Dependent Vernal Keratoconjunctivitis in a Population of Mexican Children

Leopoldo M Baiza-Duran, Ana C González-Villegas, Yussett Contreras-Rubio, Juan C Juarez-Echenique, Iris V Vizzuett-Lopez, Raul Suarez-Sanchez, Concepcion Santacruz-Valdes, Jose F Alaniz-de-la-O and Laura R Saucedo-Rodriguez

Purpose: Evaluate safety, efficacy and tolerability of 0.1% and 0.05% Cyclosporine A eye drops in Mexican children with Steroid Dependent Vernal Keratoconjunctivitis.
Methods: This was a multicenter, prospective, randomized and double masked clinical trial where the effects of 0.1 and 0.05% cyclosporine A (aqueous solution) eyedrops were evaluated in children with steroid dependent Vernal Keratoconjunctivitis. Patient evaluation was done at baseline, 2, 7, 14, 30, 60, 90, 120, 150, and 180 days. Conjunctival discharge, conjunctival papillae size, conjunctival chemosis, tearing, itching, burning sensation, photophobia and conjunctival hyperemia were the primary endpoints.
Results: 112 patients (224 eyes) with Vernal Keratoconjunctivitis were included (mean age=10.25 ± 3.83 years). 56 patients received 0.1% Cyclosporine eye drops, and another 56 patients got 0.05% Cyclosporine. Both treatments decreased the severity of all symptoms and clinical signs after 6 months (p<0.05). Treatment with ocular steroids was suspended during the study. There were no adverse events reported.
Conclusions: Cyclosporine A in aqueous solution was safe and effective in both concentrations. Topical 0.1% Cyclosporine was better than topical 0.05% Cyclosporine for improving signs and symptoms of Vernal Keratoconjunctivitis patients. Tolerability was equal for both groups. Cyclosporine treatment also allowed the cessation of topical steroid treatment.