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

NCT01272414 | Withdrawn Phase 4

• 1 other identifier: 10-0261-A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Eyelid retraction; Botulinum Toxins

Outcome Measures

Primary Outcomes (1)

• Reduction in upper lid retraction (in mm)

  4 month

Secondary Outcomes (2)

• Subjective improvement in lid retraction related dry eye symptoms

  4 months

• Subjective improvement in lid retraction related cosmesis

  4 months

Study Arms (2)

BoTox Treatment

EXPERIMENTAL

Subjects receive BoTox injection to levator complex

Drug: Botulinum Toxin Type A

Saline injection

PLACEBO COMPARATOR

Saline injection to levator complex

Drug: Saline injection

Interventions

Botulinum Toxin Type A DRUG

2-12 units in weekly 2u doses to effect

Also known as: BoTox

BoTox Treatment

Saline injection DRUG

Injection of 0.4cc 0.9% normal saline

Also known as: Placebo

Saline injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• Allergan: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Daniel B Rootman, MSc MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Nancy Tucker, MD FRCSC

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 7, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 3, 2015

Record last verified: 2010-12

Locations

CA (1)