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Double-blind, randomized, comparative study of Meditoxin versus Botox in the treatment of essential blepharospasm

Authors
 Jin Sook Yoon  ;  Jae Chan Kim  ;  Sang Yeul Lee 
Citation
 Korean Journal of Ophthalmology, Vol.23(3) : 137-141, 2009 
Journal Title
 Korean Journal of Ophthalmology 
ISSN
 1011-8942 
Issue Date
2009
Abstract
PURPOSE: To compare the efficacies and safeties of Meditoxin (Medy-Tox, Korea) and Botox in the treatment of essential blepharospasm. METHODS: We performed a double-blind, randomized, comparative trial comparing Meditoxin and Botox for treatment of blepharospasm in 60 patients from the intention-to-treat (ITT) population and 52 patients from the per-protocol (PP) population. We analyzed the improvements in severity of spasm (SS) at four weeks post-injection as a primary efficacy outcome. Changes in eyelid closing force (CF) and functional visual status (FVS) after injection were analyzed for secondary efficacy outcomes, and adverse effects were demonstrated for the safety evaluation. RESULTS: Improvement in SS was noted in 90.3% of the Meditoxin group and 86.2% of the Botox group. There were no significant differences between treatment groups in the changes of CF and FVS post-injection (p>0.05). Since the lower limit of the 95% confidence interval (-1.76% for ITT, -1.64% for PP) was over the -15% threshold, we determined that Meditoxin was not inferior to Botox in either the ITT or PP populations. Adverse effects developed in 16.1% of the Meditoxin group and 27.6% of the Botox group, but no serious adverse events were found in either group. CONCLUSIONS: Meditoxin and Botox were comparable in efficacy and safety in the treatment of essential blepharospasm
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1. College of Medicine (의과대학) > Dept. of Ophthalmology (안과학교실) > 1. Journal Papers
Yonsei Authors
Yoon, Jin Sook(윤진숙) ORCID logo https://orcid.org/0000-0002-8751-9467
Lee, Sang Yeul(이상열)
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/104285
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