Thyroid-associated OphthalmopathyPhase 3NCT01579539
The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy
A Phase 3 study testing Methylprednisolone and Esomeprazole in people with Thyroid-associated Ophthalmopathy and Dry Eye Syndrome, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Thyroid-associated ophthalmopathy (TAO), also called Graves' ophthalmopathy or thyroid eye disease, is a common orbital disease in adults. Patients with TAO, especially in its active phase, often complain about symptoms of ocular surface discomfort, including excess tearing, gritty sensation, increased sensitivity to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid-associated Ophthalmopathy, Dry Eye Syndrome
- What is being tested?
- Methylprednisolone and Esomeprazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustria
- Study dates
- 27 Jun 2013to 18 May 2017
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged over 18 years
- Active thyroid associated ophthalmopathy with clinical activity score (CAS) of each eye more than 3 or recently experienced worsening of proptosis, lid retraction, or ocular motility disturbance.
- Normal ophthalmic findings except symptoms associated with TAO
- Scheduled for treatment with systemic glucocorticoids according to the kahaly-scheme
Who cannot join
- Chronic inactive TAO
- Previous treatment with oral or intravenous glucocorticoids 3 months preceding the study
- Participation in a clinical trial in the 3 weeks before the screening visit
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
- Wearing of contact lenses
Show all 13Show fewer
- Intake of dietary supplements in the 3 months preceding the study
- Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants
- Ocular infection
- Ocular surgery in the 3 months preceding the study
- Sjögren's syndrome
- Stevens-Johnson syndrome
- Pregnancy, planned pregnancy or lactating
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
Thyroid-associated ophthalmopathy (TAO), also called Graves' ophthalmopathy or thyroid eye disease, is a common orbital disease in adults. Patients with TAO, especially in its active phase, often complain about symptoms of ocular surface discomfort, including excess tearing, gritty sensation, increased sensitivity to light and foreign-body sensation, which are similar to inflammatory ocular surface disorders such as dry-eye syndrome (DES). Incomplete blink, increased proptosis and greater palpebral fissure width in TAO accelerates tear evaporation, which increases the tear fluid's osmolarity, and results in ocular surface damage. The administration of intravenous glucocorticoids can be an effective treatment for TAO.
The rationale of the present study is to assess the effect of intravenously administered glucocorticoids on the signs of DES in patients with TAO with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film and well established methods for assessment of the severity of DES. Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.
- Being tested
- Methylprednisolone, Esomeprazole
- Keywords
- Methylprednisolone, Dry Eye Syndrome, Tear Film, Thyroid-associated ophthalmopathy
- Medical subject headings
- Graves Ophthalmopathy, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. infusion once a week for 6 weeks
EsomeprazoleDrug
40mg i.v. infusion once a week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients with moderate to severe thyroid-associated ophthalmopathy Receives: Drug: Methylprednisolone; Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear film thickness as measured with OCT
Measurements of tear film thickness with OCT will be performed 7 or less days before start of treatment, 6 weeks after start of treatment and 12 weeks after start of treatment
Measured: 13 weeks
Secondary outcomes (11)
Break up time (BUT)
Measured: 13 weeks
Visual acuity
Measured: 13 weeks
Tear film osmolarity
Measured: 13 weeks
Degree of exophthalmia
Hertel exophthalmometry
Measured: 13 weeks
Palpebral fissure width
Measured: 13 weeks
OSI (Objective Scattering Index)
Measured: 13 weeks
Tear cytokines/chemokines
Measured: 13 weeks
Impression cytology
Measured: 13 weeks
Staining of the cornea with fluorescein
Measured: 13 weeks
Schirmer I test
Measured: 13 weeks
Subjective symptoms of dry eye syndrome
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study start27 Jun 2013
- Primary completion18 May 2017
- Study completion18 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid-associated OphthalmopathyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
- Investigators
- Gerhard Garhoefer, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579539
- Sponsor's protocol ID
- OPHT-120312
- Status last verified
- Feb 2020
- First submitted
- 13 Apr 2012
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy
- ClinicalTrials.gov ID
- NCT01579539
- Acronym / sponsor ID
- OPHT-120312
- Keywords
- Methylprednisolone, Dry Eye Syndrome, Tear Film, Thyroid-associated ophthalmopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 27 Jun 2013 (actual)
- Primary completion
- 18 May 2017 (actual)
- Study completion
- 18 May 2017 (actual)
- First posted
- 18 Apr 2012 (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.
Thyroid-associated ophthalmopathy (TAO), also called Graves' ophthalmopathy or thyroid eye disease, is a common orbital disease in adults. Patients with TAO, especially in its active phase, often complain about symptoms of ocular surface discomfort, including excess tearing, gritty sensation, increased sensitivity to light and foreign-body sensation, which are similar to inflammatory ocular surface disorders such as dry-eye syndrome (DES). Incomplete blink, increased proptosis and greater palpebral fissure width in TAO accelerates tear evaporation, which increases the tear fluid's osmolarity, and results in ocular surface damage. The administration of intravenous glucocorticoids can be an effective treatment for TAO.
The rationale of the present study is to assess the effect of intravenously administered glucocorticoids on the signs of DES in patients with TAO with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film and well established methods for assessment of the severity of DES. Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Drug: Methylprednisolone, Drug: EsomeprazolePatients with moderate to severe thyroid-associated ophthalmopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged over 18 years
- Active thyroid associated ophthalmopathy with clinical activity score (CAS) of each eye more than 3 or recently experienced worsening of proptosis, lid retraction, or ocular motility disturbance.
- Normal ophthalmic findings except symptoms associated with TAO
- Scheduled for treatment with systemic glucocorticoids according to the kahaly-scheme
Key exclusion criteria (13 listed)
- Chronic inactive TAO
- Previous treatment with oral or intravenous glucocorticoids 3 months preceding the study
- Participation in a clinical trial in the 3 weeks before the screening visit
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
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 |
|---|---|---|
| Methylprednisolone500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. infusion once a week for 6 weeks | Drug | Patients |
| Esomeprazole40mg i.v. infusion once a week for 12 weeks | Drug | Patients |
Primary outcome
Tear film thickness as measured with OCT
Time frame: 13 weeks
Measurements of tear film thickness with OCT will be performed 7 or less days before start of treatment, 6 weeks after start of treatment and 12 weeks after start of treatment
11 secondary outcomes
Break up time (BUT)
Time frame: 13 weeks
Visual acuity
Time frame: 13 weeks
Tear film osmolarity
Time frame: 13 weeks
Degree of exophthalmia
Time frame: 13 weeks
Palpebral fissure width
Time frame: 13 weeks
OSI (Objective Scattering Index)
Time frame: 13 weeks
Tear cytokines/chemokines
Time frame: 13 weeks
Impression cytology
Time frame: 13 weeks
Staining of the cornea with fluorescein
Time frame: 13 weeks
Schirmer I test
Time frame: 13 weeks
Subjective symptoms of dry eye syndrome
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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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.
Gerhard Garhoefer, MD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone and Esomeprazole in people with Thyroid-associated Ophthalmopathy and Dry Eye Syndrome, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 20 Feb 2020. 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 Austria. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tear film thickness as measured with OCT (time frame: 13 weeks). 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 20 Feb 2020.