Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2026-03-03 @ 4:42 PM
Study NCT ID:
NCT01927406
Status:
WITHDRAWN
Last Update Posted:
2018-05-15
First Post:
2013-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049970', 'term': 'Graves Ophthalmopathy'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D006111', 'term': 'Graves Disease'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D000069580', 'term': 'Bimatoprost'}, {'id': 'D000069557', 'term': 'Travoprost'}, {'id': 'C485333', 'term': 'tafluprost'}, {'id': 'D000077338', 'term': 'Latanoprost'}, {'id': 'D013999', 'term': 'Timolol'}], 'ancestors': [{'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003008', 'term': 'Cloprostenol'}, {'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding source unavailable', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-14', 'studyFirstSubmitDate': '2013-08-16', 'studyFirstSubmitQcDate': '2013-08-19', 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in appearance of facial periorbital region at 6 months.', 'timeFrame': 'Baseline and 6 months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Hertel exophthalmometry at 3, 6, 9 and 12 months.', 'timeFrame': 'Baseline and 3, 6, 9 and 12 months'}, {'measure': 'Change from baseline in intraocular pressure at 3, 6, 9 and 12 months.', 'timeFrame': 'Baseline and 3, 6, 9 and 12 months'}, {'measure': 'Change from baseline in appearance of facial periorbital region at 3, 6, 9 and 12 months.', 'timeFrame': 'Baseline and 3, 6, 9 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thyroid Eye Disease', "Graves' Disease", 'Prostaglandin Analogues'], 'conditions': ['Thyroid Eye Disease', 'Ocular Hypertension', 'Glaucoma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild or moderate to severe thyroid eye disease in one or both eyes\n* age \\> 18 years\n* informed consent\n* intraocular pressure \\> 21 mmHg or glaucoma suspect or glaucoma diagnosed in one or both eyes\n* not on current prostaglandin analog intraocular pressure lowering therapy\n\nExclusion Criteria:\n\n* sight threatening thyroid eye disease\n* children \\< 18 years old\n* patients that are not compliant with treatment or follow-up\n* patients already on prostaglandin analog treatment\n* patients that undergo cosmetic periocular procedures during the study will be excluded from further follow up\n* patients that cannot tolerate prostaglandin analog treatment.\n* 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.'}, 'identificationModule': {'nctId': 'NCT01927406', 'briefTitle': 'The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.', 'orgStudyIdInfo': {'id': '26654'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prostaglandin Analog vs Timolol', 'description': '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.', 'interventionNames': ['Drug: Prostaglandin Analog', 'Drug: Timolol']}, {'type': 'EXPERIMENTAL', 'label': 'Prostaglandin Analog', 'description': '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.', 'interventionNames': ['Drug: Prostaglandin Analog']}], 'interventions': [{'name': 'Prostaglandin Analog', 'type': 'DRUG', 'otherNames': ['Bimatoprost', 'Travoprost Z', 'Tafluprost', 'Latanoprost'], 'description': '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.', 'armGroupLabels': ['Prostaglandin Analog', 'Prostaglandin Analog vs Timolol']}, {'name': 'Timolol', 'type': 'DRUG', 'otherNames': ['Timolol maleate 0.5%'], 'description': 'Timolol topical eye drop will be administered in Prostaglandin Analog vs Timolol arm only, in patients with elevated intraocular pressure in both eyes.', 'armGroupLabels': ['Prostaglandin Analog vs Timolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Hospital and Clinics', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Andrea L. Kossler, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Andrea L Kossler', 'investigatorAffiliation': 'Stanford University'}}}}