alexa 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 | Abstract
ISSN: 2155-9570

Journal of Clinical & Experimental Ophthalmology
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Research Article

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
Tel: 523330014200
Fax: 523330014271
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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Abstract

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.

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