Comparison of Different Botulinum Toxin A Injection Patterns in the Treatment of Blepharospasm

Blepharospasm Clinical Trial

Official title:

Comparison of Different Botulinum Toxin A Injection Patterns in the Treatment of Blepharospasm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02327728
• Other study ID #: ZOC00173
• Status: Recruiting
• Phase: N/A
• First received: December 18, 2014
• Last updated: December 24, 2014
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: Sun Yat-sen University
• Contact: Hui Yang, MD, PhD
• Phone: +86 13710584767
• Email: yanghui9[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of different botulinum toxin A injection patterns in treating benign essential blepharospasm and to compare their influence on condition of eye surface .

Description:

The authors performed a prospective double-blinded randomised clinical trial of 60 patients with an established diagnosis of benign essential blepharospasm from February 2013 to December 2015. Patients received a full injection pattern of 5 sites on one eye and a medial lower eyelid waived injection pattern of 4 sites on the other eye randomly. They were surveyed on ocular surface disease index (OSDI), Jankovic rating scale (JRS), blepharospasm disability index (BSDI) prior to injection and 1week, 1month and 3 months after injection. At these time points, closure of the eyelid, tear break up time (BUT), Schirmer test Ｉ, and lower lid tear meniscus height (TMH) were also measured.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• had a confirmed diagnosis of bilateral BEB

• a minimum of 24-week period since the last injection was required for all patients who had previously received multiple injections of BoNT-A.

Exclusion Criteria:

• blepharospasm of known etiology (caused by medication, injury, etc.)

• history of surgical intervention for BEB (myectomy or neurectomy)

• current ophthalmologic infection

• apraxia of eyelid opening associated with levator palpebrae dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharospasm

Intervention

Procedure:
• Botulinum toxin A injection (5 sites: 12.5U)

• Botulinum toxin A injection (4 sites: 10U)

Drug:
• Botulinum toxin A 12.5U

• Botulinum toxin A 10U

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, SunYat-senU	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
YangHui

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Jankovic rating scale (JRS) from baseline at 1week, 1month and 3 months		3 months	No
Primary	Changes of lower lid tear meniscus height (TMH) from baseline at 1week, 1month and 3 months		3 months	No
Secondary	Changes of blepharospasm disability index (BSDI) from baseline at 1week, 1month and 3 months		3 months	No
Secondary	Changes of ocular surface disease index (OSDI) from baseline at 1week, 1month and 3 months		3 months	No
Secondary	Changes of tear break up time (BUT) from baseline at 1week, 1month and 3 months		3 months	No
Secondary	Changes of closure of the eyelid from baseline at 1week, 1month and 3 months		3 months	No
Secondary	Changes of Schirmer test I from baseline at 1week, 1month and 3 months		3 months	No