NCT01564979

Brief Summary

The purpose of this study is to determine whether pretarsal and preseptal techniques of Botulinum toxin type A injection have any effect on tear functions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

5 months

First QC Date

March 18, 2012

Last Update Submit

March 27, 2012

Conditions

Hemifacial Spasm

Keywords

botulinum toxinfacial nervehemifacial spasmtears

Outcome Measures

Primary Outcomes (1)

  • tear break up time

    unit of measure; minutes

    change from baseline in tear break up time at 12 weeks

Secondary Outcomes (1)

  • schirmer's test

    change from baseline of schirmer's test at 12 weeks

Study Arms (2)

preseptal

EXPERIMENTAL
Drug: preseptal injection of botulinum toxin type A

pretarsal

EXPERIMENTAL
Drug: pretarsal injection of Botulinum toxin type A

Interventions

preseptal injection of botulinum toxin type ADRUG

botulinum toxin type A (Botox)2.5 units, 5 points

Also known as: Botox
preseptal
pretarsal injection of Botulinum toxin type ADRUG

Botulinum toxin type A 2,5 units, 5 points

Also known as: Botox
pretarsal

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient diagnosed with hemifacial spasm

You may not qualify if:

  • previous history of botulinum toxin treatment for hemifacial spasm
  • ocular surface disorders
  • tear disorders
  • evidence of infection at or around eyelids
  • pregnant woman
  • other neurologic disease, i.e. OMG
  • coagulopathy or treatment with thrombolytic agent
  • treatment with aminoglycosides, chloroquine, hydroxychloroquine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khon Kaen University

Muang, Changwat Khon Kaen, 40002, Thailand

Location

Related Publications (1)

  • Price J, O'Day J. A comparative study of tear secretion in blepharospasm and hemifacial spasm patients treated with botulinum toxin. J Clin Neuroophthalmol. 1993 Mar;13(1):67-71.

    PMID: 8501266RESULT

MeSH Terms

Conditions

Hemifacial SpasmLacerations

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesSpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • kitthisak kithaweesin, MD

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

kitthisak kitthaweesin, ND

CONTACT

6643348383kitthisak@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

March 18, 2012

First Posted

March 28, 2012

Study Start

April 1, 2012

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

March 28, 2012

Record last verified: 2012-03

Locations

TH(1)