BlepharospasmNCT02327728
Comparison of Different Botulinum Toxin A Injection Patterns in the Treatment of Blepharospasm
A study testing Botulinum toxin A injection (5 sites: 12.5U), Botulinum toxin A injection (4 sites: 10U) and Botulinum toxin A 12.5U in people with Blepharospasm, run by YangHui at 1 site in China.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharospasm
- What is being tested?
- Botulinum toxin A injection (5 sites: 12.5U), Botulinum toxin A injection (4 sites: 10U) and Botulinum toxin A 12.5U
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, SunYat-senU
Guangzhou, Guangdong, 510060
Hui Yang, MD, PhD, +86 13710584767, yanghui9@hotmail.com
About this study
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 .
Read the 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.
- Conditions
- Blepharospasm
- Being tested
- Botulinum toxin A injection (5 sites: 12.5U), Botulinum toxin A injection (4 sites: 10U), Botulinum toxin A 12.5U, Botulinum toxin A 10U
- Keywords
- blepharospasm, botulinum A, injection pattern, tear
- Medical subject headings
- Blepharospasm, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin A injection (5 sites: 12.5U)Procedure or surgery
Botulinum toxin A injection (4 sites: 10U)Procedure or surgery
Botulinum toxin A 12.5UDrug
Botulinum toxin A 10UDrug
| Study group | Role | What they receive |
|---|---|---|
| medial lower eyelid waived | Experimental | Botulinum toxin A 10U per eye subcutaneous injection at orbicularis oculi Receives: Procedure: Botulinum toxin A injection (4 sites: 10U); Drug: Botulinum toxin A 10U |
| full injection pattern | Active comparator | Botulinum toxin A 12.5U per eye subcutaneous injection at orbicularis oculi Receives: Procedure: Botulinum toxin A injection (5 sites: 12.5U); Drug: Botulinum toxin A 12.5U |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Jankovic rating scale (JRS) from baseline at 1week, 1month and 3 months
Measured: 3 months
Changes of lower lid tear meniscus height (TMH) from baseline at 1week, 1month and 3 months
Measured: 3 months
Secondary outcomes (5)
Changes of blepharospasm disability index (BSDI) from baseline at 1week, 1month and 3 months
Measured: 3 months
Changes of ocular surface disease index (OSDI) from baseline at 1week, 1month and 3 months
Measured: 3 months
Changes of tear break up time (BUT) from baseline at 1week, 1month and 3 months
Measured: 3 months
Changes of closure of the eyelid from baseline at 1week, 1month and 3 months
Measured: 3 months
Changes of Schirmer test Ｉ from baseline at 1week, 1month and 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BlepharospasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YangHui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YangHui, Sun Yat-sen University
- Investigators
- Hui Yang, MD, PhD, Principal investigator, Zhongshan Ophthalmic Center, SunYat-senU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327728
- Sponsor's protocol ID
- ZOC00173
- Status last verified
- Dec 2014
- First submitted
- 18 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26885381
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Botulinum Toxin A Injection Patterns in the Treatment of Blepharospasm
- ClinicalTrials.gov ID
- NCT02327728
- Acronym / sponsor ID
- ZOC00173
- Conditions
- Blepharospasm
- Keywords
- blepharospasm, botulinum A, injection pattern, tear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- YangHuiUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medial lower eyelid waived | Experimental | Procedure: Botulinum toxin A injection (4 sites: 10U), Drug: Botulinum toxin A 10UBotulinum toxin A 10U per eye subcutaneous injection at orbicularis oculi |
| full injection pattern | Active comparator | Procedure: Botulinum toxin A injection (5 sites: 12.5U), Drug: Botulinum toxin A 12.5UBotulinum toxin A 12.5U per eye subcutaneous injection at orbicularis oculi |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin A injection (5 sites: 12.5U) | Procedure or surgery | full injection pattern |
| Botulinum toxin A injection (4 sites: 10U) | Procedure or surgery | medial lower eyelid waived |
| Botulinum toxin A 12.5U | Drug | full injection pattern |
| Botulinum toxin A 10U | Drug | medial lower eyelid waived |
Primary outcome
Changes of Jankovic rating scale (JRS) from baseline at 1week, 1month and 3 months
Time frame: 3 months
Changes of lower lid tear meniscus height (TMH) from baseline at 1week, 1month and 3 months
Time frame: 3 months
5 secondary outcomes
Changes of blepharospasm disability index (BSDI) from baseline at 1week, 1month and 3 months
Time frame: 3 months
Changes of ocular surface disease index (OSDI) from baseline at 1week, 1month and 3 months
Time frame: 3 months
Changes of tear break up time (BUT) from baseline at 1week, 1month and 3 months
Time frame: 3 months
Changes of closure of the eyelid from baseline at 1week, 1month and 3 months
Time frame: 3 months
Changes of Schirmer test Ｉ from baseline at 1week, 1month and 3 months
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
- Derived from this study: PubMed 26885381Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Yang, MD, PhD principal investigator
Zhongshan Ophthalmic Center, SunYat-senU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin A injection (5 sites: 12.5U), Botulinum toxin A injection (4 sites: 10U) and Botulinum toxin A 12.5U in people with Blepharospasm, run by YangHui at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Yang, MD, PhD (+86 13710584767, yanghui9@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Jankovic rating scale (JRS) from baseline at 1week, 1month and 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02327728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.