Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-02-20 @ 1:31 PM
Study NCT ID:
NCT01601028
Status:
COMPLETED
Last Update Posted:
2013-10-17
First Post:
2012-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D012859', 'term': "Sjogren's Syndrome"}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-16', 'studyFirstSubmitDate': '2012-04-29', 'studyFirstSubmitQcDate': '2012-05-15', 'lastUpdatePostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum cytokine level', 'timeFrame': '16 weeks', 'description': 'IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.'}], 'secondaryOutcomes': [{'measure': 'Retinal exam', 'timeFrame': '16 weeks', 'description': 'Macular exam for monitoring Hydroxychloroquine macular toxicity'}, {'measure': 'Indicator of inflammation', 'timeFrame': '16 weeks', 'description': 'Serum ESR'}, {'measure': 'Tear production', 'timeFrame': '16 weeks', 'description': "Schirmer's test"}, {'measure': 'Subjective clinical eye complaints', 'timeFrame': '16 weeks', 'description': 'Ocular Surface Disease Index (OSDI)'}, {'measure': 'Tear cytokine level', 'timeFrame': '16 weeks', 'description': 'IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.'}, {'measure': 'Visual acuity', 'timeFrame': '16 weeks', 'description': 'Best corrected visual acuity (Snellen)'}, {'measure': 'Color test', 'timeFrame': '16 weeks', 'description': 'HRR color vision test for monitoring hydroxychloroquine retinal toxicity'}, {'measure': 'Tear breakup time', 'timeFrame': '16 weeks', 'description': 'BUT (sec)'}, {'measure': 'Corneal punctate fluorescein staining score', 'timeFrame': '16 weeks', 'description': 'Corneal staining score (National Eye Institute Scale)'}, {'measure': 'Changes in serum T-cell property', 'timeFrame': '16 weeks', 'description': 'Serum T-cell property (FACS)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Autoimmune Diseases', "Sjogren's Syndrome", 'Hydroxychloroquine'], 'conditions': ['Autoimmune Diseases', "Sjogren's Syndrome", 'Dry Eye']}, 'referencesModule': {'references': [{'pmid': '27366013', 'type': 'DERIVED', 'citation': "Yoon CH, Lee HJ, Lee EY, Lee EB, Lee WW, Kim MK, Wee WR. Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjogren's Syndrome: a Double-Blind Randomized Control Study. J Korean Med Sci. 2016 Jul;31(7):1127-35. doi: 10.3346/jkms.2016.31.7.1127. Epub 2016 Apr 20."}]}, 'descriptionModule': {'briefSummary': 'Primary Sjögren syndrome is one of the most prevalent autoimmune diseases that present with dry eye and dry mouth. But there is no proven effective treatment for Sjögren syndrome patient. The relation between toll-like receptor (TLR) and the pathogenesis of Sjögren syndrome has been reported. Hydroxychloroquine is TLR7 and TLR9 antagonist. A few studies have been reported the effectiveness of Hydroxychloroquine for Sjögren syndrome but no randomized controlled study has been done. So the investigators evaluate the effectiveness and safeness of Hydroxychloroquine for primary Sjögren syndrome by randomized controlled study (Hydroxychloroquine 300 mg once daily p.o. group (N = 30) versus placebo group (N = 30).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who is diagnosed with primary Sjögren syndrome according to American/European consensus group (AECG) criteria\n* Patient with the ability to give informed, dated and signed consent before the beginning of any proceedings related to the trial\n\nExclusion Criteria:\n\n* Previous treated by Hydroxychloroquine but enough washout time after discontinuance of treatment, patient can be enrolled. (2 wks)\n* Known cardiac disease, Respiratory disease, Renal disease, Gastrointestinal disease (except GERD)\n* Diabetes mellitus\n* Psoriasis\n* Known drug allergy or hypersensitivity\n* Previous or ongoing treatment by any drugs (include topical drug) which have effect on lacrimal system. But enough washout time after discontinuance of treatment, patient can be enrolled. (cf. SSRI, Anti-histamine, Pilocarpine, etc.)\n* Angle closer glaucoma\n* Patient who underwent previous intraocular surgery\n* Macular disease\n* Previous or ongoing treatment by drug which could have effect on macula\n* Pregnancy\n* Planning to get pregnant'}, 'identificationModule': {'nctId': 'NCT01601028', 'briefTitle': "Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome", 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': "Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome", 'orgStudyIdInfo': {'id': 'Hydroxychloroquine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine 300 mg once daily p.o.', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'Hydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks)', 'armGroupLabels': ['Hydroxychloroquine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National Unversity Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}