The Objective of This Study is to Evaluate the Efficacy and Safety of Botulax® in Patients With Essential Blepharospasm.

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• Blepharospasm 43

Keywords

• Essential Blepharospasm

Study arms

• Experimental
  Botulinum Toxin Type A (Botulax)

  Botulinum Toxin Type A (Botulax)

  Drug: Botulinum toxin type A

Interventions

• DrugBotulinum toxin type A

  Recommended initial dose to be intra-muscularly injected to the medial and contralateral pretarsal orbicularis oculi of the upper eyelid and the contralateral pretarsal orbicularis oculi of the lower eyelid is 1.25-2.5U (0.05ml \~ 0.1ml per site).

  Also known as: Botulax

Primary outcomes

1. Total score change from baseline at 4 weeks post-injection of Jankovic Rating scale

   To evaluate the change of JRS (Jankovic Rating scale) score at 4 weeks post treatment based on baseline(0 week). JRS total score will be calculated as the sum (0\~8) of two sub-scores of severity and frequency (0\~4 each for severity and frequency) of blepharospasm.

   Time frame: At 4 weeks post-injection

Secondary outcomes

1. Total score change from baseline at 16 weeks post-injection of Jankovic Rating scale

   To evaluate the change of JRS (Jankovic Rating scale) score at 16 weeks post treatment based on baseline(0 week)

   Time frame: At 0 weeks and 16 weeks post-injection

2. Change from baseline at 4 weeks and 16 weeks of Disability Index

   To evaluate the change of Blepharospasm Disability Index at 4 weeks and 16 weeks post treatment. Functional disability assessment scale will be assessed as functional disability score. Functional disability assessment scale consists of 6 daily activities (reading, watching television, household activities (cleaning, etc.), mobility, driving, work).

   Time frame: At 4 weeks and 16 weeks post-injection

3. Global Response evaluated by investigator at 4 weeks and 16 weeks after post-injection

   To evaluate the Investigator's assessment of global response at Weeks 4 and 16 after treatment. At Weeks 4 and 16 Visits after treatment, the investigator will assess global response on a 9-point scale from -4 (marked worsening) to +4 (Complete abolition of all signs and symptoms).

   Time frame: At 4 weeks and 16 weeks post-injection

4. Change from baseline at 4 weeks and 16 weeks of WHO-Quality of Life(QOL)

   To evaluate the change in WHO-Quality of Life (QoL) at Weeks 4 and 16 after treatment from baseline WHOQOL will be assessed by the brief Korean version of WHOQOL (WHOQOL-BREF). The Korean WHOQOL-BREF consists of a total of 26 subscales in 4 domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Items in each subscale are in a range from 1 (not at all or very dissatisfied) to 5 (very much or very satisfied).

   Time frame: At 4 weeks and 16 weeks post-injection