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-Duran1*, Ana C González-Villegas1, Yussett Contreras-Rubio1, Juan C Juarez-Echenique2, Iris V Vizzuett-Lopez2, Raul Suarez-Sanchez3, Concepcion Santacruz-Valdes3, Jose F Alaniz-de-la-O4 and Laura R Saucedo-Rodriguez4|
|1Clinical Research Department, Laboratorios Sophia, Guadalajara, Mexico|
|2Instituto Nacional de Pediatría, Mexico City, Mexico|
|3Instituto Oftalmológico Fundación Conde de Valenciana, Mexico City, Mexico|
|4Hospital Civil de Guadalajara, Guadalajara, Mexico|
|Corresponding Author :||Leopoldo Baiza-Duran
Av. Paseo del Norte No. 5255
Fracc. Guadalajara Technology Park
Zapopan, Jalisco, Mexico C.P. 45010
E-mail: [email protected]
|Received October 28, 2010; Accepted December 03, 2010; Published December 04, 2010|
|Citation: Baiza-Duran LM, González-Villegas AC, Contreras-Rubio Y, Juarez- Echenique JC, Vizzuett-Lopez IV, et al. (2010) 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. J Clinic Experiment Ophthalmol 1:115. doi:10.4172/2155-9570.1000115|
|Copyright: © 2010 Baiza-Duran LM, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.|
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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.