Double-blind, randomized, comparative study of Meditoxin versus Botox in the treatment of essential blepharospasm.
OBJECTIVE
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.
Yoon
Jin Sook
JS
Department of Ophthalmology, Institute of Vision Research, University of Yonsei, Seoul, Korea.
Kim
Jae Chan
JC
Lee
Sang Yeul
SY
D000368:Aged; D001764:Blepharospasm / Q000188:drug therapy* / Q000503:physiopathology; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A