CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Botulinum Toxin Type A 100Unit/Vial (Product) +1 moredrug
Likely dose
Botulinum Toxin Type A 100Unit/Vial (Product)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03508882
NCT03508882Phase 4Completed
CompareCT.gov

Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm: a Randomized, Triple-blind, Placebo-controlled, Cross-over Clinical Trial

The University of Hong Kong·interventional·Posted Apr 26, 2018·Updated Apr 26, 2019

In Brief

A Phase 4 clinical trial evaluating Botulinum Toxin Type A 100Unit/Vial (Product) and Saline Solution for Injection for Blepharospasm and 2 related conditions. Completed, enrolled 100 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlepharospasm, Hemifacial Spasm, Botulinum Toxins, Type A
Countries--
CollaboratorsFood and Health Bureau, Hong Kong

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 26, 2018
Enrollment StartJul 1, 2015
Primary CompletionOct 31, 2017
Study CompletionFeb 20, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.2 years ago

Interventions

Botulinum Toxin Type A 100Unit/Vial (Product)drug

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

Saline Solution for Injectiondrug

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).