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

This study has been withdrawn prior to enrollment.
(lack of funding)
Information provided by:
University of Toronto Identifier:
First received: January 6, 2011
Last updated: June 2, 2015
Last verified: December 2010
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.

Condition Intervention Phase
Graves Ophthalmopathy
Drug: Botulinum Toxin Type A
Drug: Saline injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Reduction in upper lid retraction (in mm) [ Time Frame: 4 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective improvement in lid retraction related dry eye symptoms [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    ocular surface disease index score

  • Subjective improvement in lid retraction related cosmesis [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Graves Orbitopathy quality of life score

Enrollment: 0
Study Start Date: January 2011
Study Completion Date: February 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BoTox Treatment
Subjects receive BoTox injection to levator complex
Drug: Botulinum Toxin Type A
2-12 units in weekly 2u doses to effect
Other Name: BoTox
Placebo Comparator: Saline injection
Saline injection to levator complex
Drug: Saline injection
Injection of 0.4cc 0.9% normal saline
Other Name: Placebo


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Active stage thyroid orbitopathy, as determined by symptom onset of under 6 months.
  • Upper eyelid retraction of 1mm or greater.
  • Complaining of either significant ocular symptoms (despite appropriate use of ocular lubricants), or bothered by the cosmetic deformity associated with the eyelid retraction.

Exclusion Criteria:

  • Less than 18 years of age
  • Age over 65 years
  • Pregnant or nursing
  • Known peripheral neuropathy or neuromuscular junction disorder
  • Demonstrated allergy to BoTox
  • Current infection over the injection site
  • Are currently taking any of the following medications: aminoglycosides, penicillamine, quinine, and calcium channel blockers.
  • Previous or concurrent prednisone therapy
  • Undergone previous upper eyelid surgery
  • Severe vision threatening TO
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Please refer to this study by its identifier: NCT01272414

Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
University of Toronto
Principal Investigator: Daniel B Rootman, MSc MD University of Toronto
Principal Investigator: Nancy Tucker, MD FRCSC University of Toronto
  More Information

Responsible Party: Dr Nancy Tucker, MD FRCSC, University of Toronto Identifier: NCT01272414     History of Changes
Other Study ID Numbers: 10-0261-A 
Study First Received: January 6, 2011
Last Updated: June 2, 2015
Health Authority: Canada: Health Canada

Keywords provided by University of Toronto:
Eyelid retraction
Botulinum Toxins

Additional relevant MeSH terms:
Eye Diseases
Graves Ophthalmopathy
Autoimmune Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Immune System Diseases
Orbital Diseases
Thyroid Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Cholinergic Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuromuscular Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on May 26, 2016