Comparison of Different Botulinum Toxin A Injection Patterns in the Treatment of Blepharospasm
1 other identifier
interventional
120
1 country
1
Brief 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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 18, 2014
CompletedFirst Posted
Study publicly available on registry
December 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 30, 2014
December 1, 2014
2.8 years
December 18, 2014
December 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes of Jankovic rating scale (JRS) from baseline at 1week, 1month and 3 months
3 months
Changes of lower lid tear meniscus height (TMH) from baseline at 1week, 1month and 3 months
3 months
Secondary Outcomes (5)
Changes of blepharospasm disability index (BSDI) from baseline at 1week, 1month and 3 months
3 months
Changes of ocular surface disease index (OSDI) from baseline at 1week, 1month and 3 months
3 months
Changes of tear break up time (BUT) from baseline at 1week, 1month and 3 months
3 months
Changes of closure of the eyelid from baseline at 1week, 1month and 3 months
3 months
Changes of Schirmer test Ｉ from baseline at 1week, 1month and 3 months
3 months
Study Arms (2)
medial lower eyelid waived
EXPERIMENTALBotulinum toxin A 10U per eye subcutaneous injection at orbicularis oculi
full injection pattern
ACTIVE COMPARATORBotulinum toxin A 12.5U per eye subcutaneous injection at orbicularis oculi
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- YangHuilead
Study Sites (1)
Zhongshan Ophthalmic Center, SunYat-senU
Guangzhou, Guangdong, 510060, China
Related Publications (1)
Yang H, Lu J, Zhao X, Ding X, Wang Z, Cai X, Luo Y, Lu L. Comparison of Two Botulinum Neurotoxin A Injection Patterns with or without the Medial Lower Eyelid in the Treatment of Blepharospasm. J Ophthalmol. 2016;2016:5957812. doi: 10.1155/2016/5957812. Epub 2016 Jan 14.
PMID: 26885381DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hui Yang, MD, PhD
Zhongshan Ophthalmic Center, SunYat-senU
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD, Associate Professor
Study Record Dates
First Submitted
December 18, 2014
First Posted
December 30, 2014
Study Start
February 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 30, 2014
Record last verified: 2014-12