Graves OphthalmopathyPhase 4NCT01272414
Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction
A Phase 4 study testing Botulinum Toxin Type A and Saline injection in people with Graves Ophthalmopathy, run by University of Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graves Ophthalmopathy
- What is being tested?
- Botulinum Toxin Type A and Saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Feb 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Botulinum Toxin Type A, Saline injection
- Keywords
- Eyelid retraction, Botulinum Toxins
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called BoTox
2-12 units in weekly 2u doses to effect
Saline injectionDrug
Also called Placebo
Injection of 0.4cc 0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| BoTox Treatment | Experimental | Subjects receive BoTox injection to levator complex Receives: Drug: Botulinum Toxin Type A |
| Saline injection | Placebo comparator | Saline injection to levator complex Receives: Drug: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in upper lid retraction (in mm)
Measured: 4 month
Secondary outcomes (2)
Subjective improvement in lid retraction related dry eye symptoms
ocular surface disease index score
Measured: 4 months
Subjective improvement in lid retraction related cosmesis
Graves Orbitopathy quality of life score
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionFeb 2012
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves OphthalmopathyStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Investigators
- Daniel B Rootman, MSc MD, Principal investigator, University of TorontoNancy Tucker, MD FRCSC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272414
- Sponsor's protocol ID
- 10-0261-A
- Status last verified
- Dec 2010
- First submitted
- 6 Jan 2011
- Last updated
- 3 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction
- ClinicalTrials.gov ID
- NCT01272414
- Acronym / sponsor ID
- 10-0261-A
- Conditions
- Graves Ophthalmopathy
- Keywords
- Eyelid retraction, Botulinum Toxins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BoTox Treatment | Experimental | Drug: Botulinum Toxin Type ASubjects receive BoTox injection to levator complex |
| Saline injection | Placebo comparator | Drug: Saline injectionSaline injection to levator complex |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- Less than 18 years of age
- Age over 65 years
- Pregnant or nursing
- Known peripheral neuropathy or neuromuscular junction disorder
- Demonstrated allergy to BoTox
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type AAlso: BoTox2-12 units in weekly 2u doses to effect | Drug | BoTox Treatment |
| Saline injectionAlso: PlaceboInjection of 0.4cc 0.9% normal saline | Drug | Saline injection |
Primary outcome
Reduction in upper lid retraction (in mm)
Time frame: 4 month
2 secondary outcomes
Subjective improvement in lid retraction related dry eye symptoms
Time frame: 4 months
Subjective improvement in lid retraction related cosmesis
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel B Rootman, MSc MD principal investigator
University of Toronto
Nancy Tucker, MD FRCSC principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type A and Saline injection in people with Graves Ophthalmopathy, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in upper lid retraction (in mm) (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.