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Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction

NCT01272414 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-06-03

No results posted yet for this study

Summary

Currently there are few therapeutic options for the treatment of lid retraction secondary to thyroid orbitopathy (TO) during the active stages of the disease. BoTox injection is capable of creating a ptosis, that in the setting of TO can return the upper lid to a more physiologic position, thus improving cosmesis, corneal lubrication and potentially quiescent stage lid position. This investigation aims to examine the properties of this relationship.

Conditions

  • Graves Ophthalmopathy

Interventions

DRUG

Botulinum Toxin Type A

2-12 units in weekly 2u doses to effect

DRUG

Saline injection

Injection of 0.4cc 0.9% normal saline

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • University of Toronto

    lead OTHER

Principal Investigators

  • Daniel B Rootman, MSc MD · University of Toronto

  • Nancy Tucker, MD FRCSC · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-01-31
Completion
2012-02-29

Countries

  • Canada

Study Locations

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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 NCT01272414 on ClinicalTrials.gov