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

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ClinicalTrials.gov Identifier: NCT02327728
Recruitment Status : Unknown
Verified December 2014 by YangHui, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : December 30, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
YangHui, Sun Yat-sen University

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 .

Condition or disease Intervention/treatment Phase
Blepharospasm Procedure: Botulinum toxin A injection (5 sites: 12.5U) Procedure: Botulinum toxin A injection (4 sites: 10U) Drug: Botulinum toxin A 12.5U Drug: Botulinum toxin A 10U Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Different Botulinum Toxin A Injection Patterns in the Treatment of Blepharospasm
Study Start Date : February 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: medial lower eyelid waived
Botulinum toxin A 10U per eye subcutaneous injection at orbicularis oculi
Procedure: Botulinum toxin A injection (4 sites: 10U)
Drug: Botulinum toxin A 10U
Active Comparator: full injection pattern
Botulinum toxin A 12.5U per eye subcutaneous injection at orbicularis oculi
Procedure: Botulinum toxin A injection (5 sites: 12.5U)
Drug: Botulinum toxin A 12.5U



Primary Outcome Measures :
  1. Changes of Jankovic rating scale (JRS) from baseline at 1week, 1month and 3 months [ Time Frame: 3 months ]
  2. Changes of lower lid tear meniscus height (TMH) from baseline at 1week, 1month and 3 months [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Changes of blepharospasm disability index (BSDI) from baseline at 1week, 1month and 3 months [ Time Frame: 3 months ]
  2. Changes of ocular surface disease index (OSDI) from baseline at 1week, 1month and 3 months [ Time Frame: 3 months ]
  3. Changes of tear break up time (BUT) from baseline at 1week, 1month and 3 months [ Time Frame: 3 months ]
  4. Changes of closure of the eyelid from baseline at 1week, 1month and 3 months [ Time Frame: 3 months ]
  5. Changes of Schirmer test I from baseline at 1week, 1month and 3 months [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327728


Contacts
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Contact: Hui Yang, MD, PhD +86 13710584767 yanghui9@hotmail.com

Locations
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China, Guangdong
Zhongshan Ophthalmic Center, SunYat-senU Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Hui Yang, MD, PhD    +86 13710584767    yanghui9@hotmail.com   
Sponsors and Collaborators
YangHui
Investigators
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Principal Investigator: Hui Yang, MD, PhD Zhongshan Ophthalmic Center, SunYat-senU

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: YangHui, MD, PhD, Associate Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02327728     History of Changes
Other Study ID Numbers: ZOC00173
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Keywords provided by YangHui, Sun Yat-sen University:
blepharospasm
botulinum A
injection pattern
tear
Additional relevant MeSH terms:
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Blepharospasm
Eyelid Diseases
Eye Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents