Thyroid Eye DiseasePhase 4NCT01927406
The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.
A Phase 4 study testing Prostaglandin Analog and Timolol in people with Thyroid Eye Disease and Ocular Hypertension, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the potential secondary beneficial effect of prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study aims to determine if PA would change the course of the orbitopathy in TED patients by altering the progression of the common features of TED… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Eye Disease, Ocular Hypertension, Glaucoma
- What is being tested?
- Prostaglandin Analog and Timolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild or moderate to severe thyroid eye disease in one or both eyes
- age > 18 years
- informed consent
- intraocular pressure > 21 mmHg or glaucoma suspect or glaucoma diagnosed in one or both eyes
- not on current prostaglandin analog intraocular pressure lowering therapy
Who cannot join
- sight threatening thyroid eye disease
- children < 18 years old
- patients that are not compliant with treatment or follow-up
- patients already on prostaglandin analog treatment
- patients that undergo cosmetic periocular procedures during the study will be excluded from further follow up
- patients that cannot tolerate prostaglandin analog treatment.
- patients with bilateral thyroid eye disease and elevated intraocular pressures that cannot tolerate treatment with timolol or an alternative intraocular pressure lowering medication such as trusopt, combigan, cosopt.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Stanford, California, 94304
About this study
The purpose of this study is to evaluate the potential secondary beneficial effect of prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study aims to determine if PA would change the course of the orbitopathy in TED patients by altering the progression of the common features of TED, including fatty hypertrophy, proptosis, eyelid retraction and optic nerve compression. The eyes with thyroid eye disease and elevated intraocular pressure will be randomised to the PA treatment and the other eye will serve as a control eye and will be treated with Timolol.
- Conditions
- Thyroid Eye Disease, Ocular Hypertension, Glaucoma
- Being tested
- Prostaglandin Analog, Timolol
- Keywords
- Thyroid Eye Disease, Graves' Disease, Prostaglandin Analogues
- Medical subject headings
- Graves Ophthalmopathy, Ocular Hypertension, Glaucoma, Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostaglandin AnalogDrug
Also called Bimatoprost, Travoprost Z, Tafluprost, Latanoprost
The first choice drug from group of Prostaglandin Analogues will be bimatoprost, if patient will suffer from any side effect of this drug another drug from this group will be administer. If patient turned out to cannot tolerate the prostaglandin analog therapy then the exclusion criteria will be met.
TimololDrug
Also called Timolol maleate 0.5%
Timolol topical eye drop will be administered in Prostaglandin Analog vs Timolol arm only, in patients with elevated intraocular pressure in both eyes.
| Study group | Role | What they receive |
|---|---|---|
| Prostaglandin Analog vs Timolol | Experimental | In this group, with thyroid eye disease and increased intraocular pressure in both eyes, prostaglandin analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one - randomised eye. Timolol 0.5% eye drop will be administered topically in second, control eye, two times a day. Receives: Drug: Prostaglandin Analog; Drug: Timolol |
| Prostaglandin Analog | Experimental | In this group, with thyroid eye disease and increased intraocular pressure in only one eye Prostaglandin Analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one, affected eye. Receives: Drug: Prostaglandin Analog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in appearance of facial periorbital region at 6 months.
Measured: Baseline and 6 months
Secondary outcomes (3)
Change from baseline in Hertel exophthalmometry at 3, 6, 9 and 12 months.
Measured: Baseline and 3, 6, 9 and 12 months
Change from baseline in intraocular pressure at 3, 6, 9 and 12 months.
Measured: Baseline and 3, 6, 9 and 12 months
Change from baseline in appearance of facial periorbital region at 3, 6, 9 and 12 months.
Measured: Baseline and 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startJun 2014 (estimated)
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Funding source unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea L Kossler, Stanford University
- Investigators
- Andrea L. Kossler, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927406
- Sponsor's protocol ID
- 26654
- Status last verified
- May 2018
- First submitted
- 16 Aug 2013
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.
- ClinicalTrials.gov ID
- NCT01927406
- Acronym / sponsor ID
- 26654
- Conditions
- Thyroid Eye Disease, Ocular Hypertension, Glaucoma
- Keywords
- Thyroid Eye Disease, Graves' Disease, Prostaglandin Analogues
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding source unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2014 (estimated)
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 22 Aug 2013 (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.
The purpose of this study is to evaluate the potential secondary beneficial effect of prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study aims to determine if PA would change the course of the orbitopathy in TED patients by altering the progression of the common features of TED, including fatty hypertrophy, proptosis, eyelid retraction and optic nerve compression. The eyes with thyroid eye disease and elevated intraocular pressure will be randomised to the PA treatment and the other eye will serve as a control eye and will be treated with Timolol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostaglandin Analog vs Timolol | Experimental | Drug: Prostaglandin Analog, Drug: TimololIn this group, with thyroid eye disease and increased intraocular pressure in both eyes, prostaglandin analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one - randomised eye. Timolol 0.5% eye drop will be administered topically in second, control eye, two times a day. |
| Prostaglandin Analog | Experimental | Drug: Prostaglandin AnalogIn this group, with thyroid eye disease and increased intraocular pressure in only one eye Prostaglandin Analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one, affected eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- mild or moderate to severe thyroid eye disease in one or both eyes
- age > 18 years
- informed consent
- intraocular pressure > 21 mmHg or glaucoma suspect or glaucoma diagnosed in one or both eyes
- not on current prostaglandin analog intraocular pressure lowering therapy
Key exclusion criteria (7 listed)
- sight threatening thyroid eye disease
- children < 18 years old
- patients that are not compliant with treatment or follow-up
- patients already on prostaglandin analog treatment
- patients that undergo cosmetic periocular procedures during the study will be excluded from further follow up
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 |
|---|---|---|
| Prostaglandin AnalogAlso: Bimatoprost, Travoprost Z, Tafluprost, LatanoprostThe first choice drug from group of Prostaglandin Analogues will be bimatoprost, if patient will suffer from any side effect of this drug another drug from this group will be administer. If patient turned out to cannot tolerate the prostaglandin analog therapy then the exclusion criteria will be met. | Drug | Prostaglandin Analog, Prostaglandin Analog vs Timolol |
| TimololAlso: Timolol maleate 0.5%Timolol topical eye drop will be administered in Prostaglandin Analog vs Timolol arm only, in patients with elevated intraocular pressure in both eyes. | Drug | Prostaglandin Analog vs Timolol |
Primary outcome
Change from baseline in appearance of facial periorbital region at 6 months.
Time frame: Baseline and 6 months
3 secondary outcomes
Change from baseline in Hertel exophthalmometry at 3, 6, 9 and 12 months.
Time frame: Baseline and 3, 6, 9 and 12 months
Change from baseline in intraocular pressure at 3, 6, 9 and 12 months.
Time frame: Baseline and 3, 6, 9 and 12 months
Change from baseline in appearance of facial periorbital region at 3, 6, 9 and 12 months.
Time frame: Baseline and 3, 6, 9 and 12 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 15 May 2018.
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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.
Andrea L. Kossler, M.D. principal investigator
Stanford University
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 Prostaglandin Analog and Timolol in people with Thyroid Eye Disease and Ocular Hypertension, run by Stanford University at 1 site in United States.
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 5 inclusion and 7 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 15 May 2018. 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 United States. 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 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?
Change from baseline in appearance of facial periorbital region at 6 months. (time frame: Baseline and 6 months). 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 15 May 2018.