MedTrace Logo

Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm

NCT03508882 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-04-26

No results posted yet for this study

Summary

A triple-masked placebo-controlled trial assessing the efficacy and safety of pretarsal versus preseptal botulinum toxin for patients with eyelid spasm. The investigators hypothesize injection of botulinum toxin into the pretarsal orbicularis oculi muscle will have greater clinical efficacy, better measured quality of life, fewer complications, and better cost effectiveness in comparison to a preseptal pattern of injection.

Conditions

  • Blepharospasm
  • Hemifacial Spasm
  • Botulinum Toxins, Type A

Interventions

DRUG

Botulinum Toxin Type A 100Unit/Vial (Product)

Botulinum Toxin Type A 100Unit/Vial (Product) comes as a dry powder and is routinely reconstituted with Saline Solution for Injection

DRUG

Saline Solution for Injection

The placebo consists of vehicle only. Saline Solution for Injection is the vehicle substance normally used to reconstitute Botulinum Toxin Type A (see 1st Intervention above).

Sponsors & Collaborators

  • Food and Health Bureau, Hong Kong

    collaborator OTHER_GOV

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Marcus M Marcet, MD · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2017-10-31
Completion
2019-02-20

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03508882 on ClinicalTrials.gov