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

Sponsor

University of Toronto (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01272414

Collaborator

Allergan (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Graves Ophthalmopathy	Drug: Botulinum Toxin Type A Drug: Saline injection	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: BoTox
Placebo Comparator: Saline injection Saline injection to levator complex	Drug: Saline injection Injection of 0.4cc 0.9% normal saline Other Names: Placebo

Arm

Intervention/Treatment

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 Names:

BoTox

Placebo Comparator: Saline injection

Saline injection to levator complex

Drug: Saline injection

Injection of 0.4cc 0.9% normal saline

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

Reduction in upper lid retraction (in mm) [4 month]

Secondary Outcome Measures

Subjective improvement in lid retraction related dry eye symptoms [4 months]
ocular surface disease index score
Subjective improvement in lid retraction related cosmesis [4 months]
Graves Orbitopathy quality of life score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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