Double-Blind, Randomized, Comparative Study of Meditoxin® Versus Botox ® in the Treatment of Essential Blepharospasm

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 in-jection 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). Sinc