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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of Toronto.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Allergan
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT01272414
First received: January 6, 2011
Last updated: September 14, 2011
Last verified: December 2010

January 6, 2011
September 14, 2011
January 2011
January 2012   (final data collection date for primary outcome measure)
Reduction in upper lid retraction (in mm) [ Time Frame: 4 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01272414 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Graves Ophthalmopathy
  • Drug: Botulinum Toxin Type A
    2-12 units in weekly 2u doses to effect
    Other Name: BoTox
  • Drug: Saline injection
    Injection of 0.4cc 0.9% normal saline
    Other Name: Placebo
  • Experimental: BoTox Treatment
    Subjects receive BoTox injection to levator complex
    Intervention: Drug: Botulinum Toxin Type A
  • Placebo Comparator: Saline injection
    Saline injection to levator complex
    Intervention: Drug: Saline injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
Not Provided
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Nancy Tucker, MD FRCSC (416) 586-4800 ext 6757 nancytucker@me.com
Contact: Daniel B Rootman, MSc MD (416) 586-4800 ext 6757 dan.rootman@gmail.com
Canada
 
NCT01272414
10-0261-A
Not Provided
Dr Nancy Tucker, MD FRCSC, University of Toronto
University of Toronto
Allergan
Principal Investigator: Daniel B Rootman, MSc MD University of Toronto
Principal Investigator: Nancy Tucker, MD FRCSC University of Toronto
University of Toronto
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP