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

This study has been withdrawn prior to enrollment.
(lack of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272414
First Posted: January 7, 2011
Last Update Posted: June 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by:
University of Toronto
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]

Secondary Outcome Measures:
  • Subjective improvement in lid retraction related dry eye symptoms [ Time Frame: 4 months ]
    ocular surface disease index score

  • Subjective improvement in lid retraction related cosmesis [ Time Frame: 4 months ]
    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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272414


Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
University of Toronto
Allergan
Investigators
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
ClinicalTrials.gov Identifier: NCT01272414     History of Changes
Other Study ID Numbers: 10-0261-A
First Submitted: January 6, 2011
First Posted: January 7, 2011
Last Update Posted: June 3, 2015
Last Verified: December 2010

Keywords provided by University of Toronto:
Eyelid retraction
Botulinum Toxins

Additional relevant MeSH terms:
Eye Diseases
Graves Ophthalmopathy
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents