Back to resultsUse of Botox in the Management of Thyroid Related Upper Eyelid Retraction
Primary Purpose
Graves Ophthalmopathy
Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Saline injection
Sponsored by
About this trial
This is an interventional treatment trial for Graves Ophthalmopathy focused on measuring Eyelid retraction, Botulinum Toxins
Eligibility 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
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BoTox Treatment
Saline injection
Arm Description
Subjects receive BoTox injection to levator complex
Saline injection to levator complex
Outcomes
Primary Outcome Measures
Reduction in upper lid retraction (in mm)
Secondary Outcome Measures
Subjective improvement in lid retraction related dry eye symptoms
ocular surface disease index score
Subjective improvement in lid retraction related cosmesis
Graves Orbitopathy quality of life score
Full Information
NCT ID
NCT01272414
First Posted
January 6, 2011
Last Updated
June 2, 2015
Sponsor
University of Toronto
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT01272414
Brief Title
Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funding
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Toronto
Collaborators
Allergan
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Ophthalmopathy
Keywords
Eyelid retraction, Botulinum Toxins
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BoTox Treatment
Arm Type
Experimental
Arm Description
Subjects receive BoTox injection to levator complex
Arm Title
Saline injection
Arm Type
Placebo Comparator
Arm Description
Saline injection to levator complex
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
BoTox
Intervention Description
2-12 units in weekly 2u doses to effect
Intervention Type
Drug
Intervention Name(s)
Saline injection
Other Intervention Name(s)
Placebo
Intervention Description
Injection of 0.4cc 0.9% normal saline
Primary Outcome Measure Information:
Title
Reduction in upper lid retraction (in mm)
Time Frame
4 month
Secondary Outcome Measure Information:
Title
Subjective improvement in lid retraction related dry eye symptoms
Description
ocular surface disease index score
Time Frame
4 months
Title
Subjective improvement in lid retraction related cosmesis
Description
Graves Orbitopathy quality of life score
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel B Rootman, MSc MD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Tucker, MD FRCSC
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction
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