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

Graves Ophthalmopathy Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01272414
• Other study ID #: 10-0261-A
• Status: Withdrawn
• Phase: Phase 4
• First received: January 6, 2011
• Last updated: June 2, 2015
• Start date: January 2011
• Est. completion date: February 2012

Study information

• Verified date: December 2010
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy

Intervention

Drug:
• Botulinum Toxin Type A
2-12 units in weekly 2u doses to effect
• Saline injection
Injection of 0.4cc 0.9% normal saline

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Allergan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in upper lid retraction (in mm)		4 month	No
Secondary	Subjective improvement in lid retraction related dry eye symptoms	ocular surface disease index score	4 months	No
Secondary	Subjective improvement in lid retraction related cosmesis	Graves Orbitopathy quality of life score	4 months	No