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A comparative clinical trial of the efficacy of two different aqueous solutions of cyclosporine for the treatment of moderate-to-severe dry eye syndrome.

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A comparative clinical trial of the efficacy of two different aqueous solutions of cyclosporine for the treatment of moderate-to-severe dry eye syndrome.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Baiza-Durán, Leopoldo Medrano-Palafox, Javier Hernández-Quintela, Everardo Lozano-Alcazar, Jaime Alaníz-de la O., J. Félix
Description	Author Affiliation: Baiza-Durán L ( Laboratorios Sophia, S.A. de C.V., Av. Paseo del Norte 5255, Guadalajara Technology Park, Zapopan, Jalisco, México. drbvista@sophia.com.mx)
Abstract	OBJECTIVE: To evaluate the efficacy and safety of two different concentrations of cyclosporine A (CsA) in aqueous solution compared to vehicle in patients with dry eye syndrome. DESIGN: Multicentre, randomised, double-masked, vehicle-controlled, clinical trial. METHODS: A total of 183 patients were enrolled and randomised to either CsA 1% (group A), CsA 0.05% (group B) or vehicle only (group C). The main objective was to evaluate the efficacy of CsA aqueous solution in the reduction of signs and symptoms in patients with moderate to severe dry eye disease. RESULTS: An early (day 21) statistically significant improvement (p<0.05) was evident in four symptoms and three ocular signs in group A. An equivalent improvement in three symptoms and three ocular signs was demonstrated in group B. A significant improvement was identified in two symptoms and two ocular signs in group C. Comparing the three groups together, group A performed better in four symptoms than group B did with just one symptom. Group C did not show significant improvement. At day 42, group A showed improvement in four symptoms, while group B showed improvement in one symptom and one ocular sign. CONCLUSIONS: Cyclosporine A reduced complaints and improved major ocular signs in patients with moderate-to-severe dry eye disease. The group treated with the 0.1% cyclosporine A aqueous solution outperformed the other groups.
File Format	HTM / HTML
ISSN	00071161
Issue Number	10
Volume Number	94
e-ISSN	14682079
Journal	British Journal of Ophthalmology
Language	English
Publisher	BMJ Publishing Group Ltd.
Publisher Date	2010-10-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Dry Eye Syndromes Adverse Effects Comparative Study Humans Middle Aged Drug Therapy Male Treatment Outcome Administration & Dosage Cyclosporine Randomized Controlled Trial Journal Article Drug Carriers Discipline Ophthalmology Ophthalmic Solutions Female Multicenter Study Aged
Content Type	Text
Resource Type	Article
Subject	Ophthalmology Sensory Systems Cellular and Molecular Neuroscience

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