Comparisons for Evaluation of Efficacy and Safety of Cyclosporin A 0.05% Ophthalmic Emulsion Treatment Groups
Journal of the Korean Ophthalmological Society
;
: 1849-1856, 2016.
Artigo
em Coreano
| WPRIM
| ID: wpr-124586
ABSTRACT
PURPOSE:
To evaluate and compare the efficacy and safety of cyclosporine 0.05% (Cyporin N eye drops 0.05%) to an active comparator (Restasis®) in moderate to severe dry eye patients.METHODS:
This is a multicenter, randomized, double-blind, parallel, active control, non-inferiority, phase III study. Patients had a 2-week run-in period (during the run-in period, patients used artificial tears, if applicable), and afterward 158 patients were randomly assigned treatment for 12 weeks with cyclosporine 0.05% (with artificial tears, if applicable), in which the efficacy and safety were evaluated every four weeks.RESULTS:
Corneal staining tests showed that in the per protocol set group, the study group was not inferior to the control group; the results for the full analysis set analytic group were the same. The number of adverse events reported from the 158 patients was not significantly different between groups (p = 0.1107). Additionally, other evaluations, including tolerability evaluations, clinical pathology examinations, and vital signs, show that there is no difference in terms of safety between the groups.CONCLUSIONS:
Cyclosporine A 0.05% (Cyporin N eye drops 0.05%) is considered to have the same efficacy and safety compared to the active comparator.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Soluções Oftálmicas
/
Patologia Clínica
/
Síndromes do Olho Seco
/
Ciclosporina
/
Sinais Vitais
/
Lubrificantes Oftálmicos
Tipo de estudo:
Ensaio Clínico Controlado
/
Guia de Prática Clínica
Limite:
Humanos
Idioma:
Coreano
Revista:
Journal of the Korean Ophthalmological Society
Ano de publicação:
2016
Tipo de documento:
Artigo
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