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

NCT ID: NCT01272414

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-02-29

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.

Conditions

Graves Ophthalmopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BoTox Treatment

Subjects receive BoTox injection to levator complex

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

2-12 units in weekly 2u doses to effect

Saline injection

Saline injection to levator complex

Group Type: PLACEBO_COMPARATOR

Saline injection

Intervention Type: DRUG

Injection of 0.4cc 0.9% normal saline

Interventions

Botulinum Toxin Type A

2-12 units in weekly 2u doses to effect

Intervention Type: DRUG

Saline injection

Injection of 0.4cc 0.9% normal saline

Intervention Type: DRUG

Other Intervention Names

BoTox; Placebo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

University of Toronto

Principal Investigators

Daniel B Rootman, MSc MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Nancy Tucker, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

10-0261-A

Identifier Type: -

Identifier Source: org_study_id