Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-03-05 @ 4:27 PM
Study NCT ID:
NCT04819269
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2021-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D012859', 'term': "Sjogren's Syndrome"}, {'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye 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': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening.', 'timeFrame': '85 days'}, {'measure': 'Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening.', 'timeFrame': '85 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oligonucleotide', 'siRNA', 'keratoconjunctivitis sicca', 'SYL1001'], 'conditions': ['Dry Eye Disease', 'Sjögren Syndrome']}, 'descriptionModule': {'briefSummary': "This study will examine the efficacy and safety of tivanisiran sodium eye drops versus vehicle after a 2-week run-in phase when dosed once daily for 3 months in subjects with signs and symptoms of dry eye disease (DED) due to Sjögren's Syndrome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is a male or a female aged ≥ 18 years\n* Have given their written consent to participate in the study\n* Use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection\n* Willing to not use AT or autologous serum for the study duration\n* VAS scale for Dry Eye Symptom Score ≥ 40\n* Total CFS ≥ 5\n* Schirmer's test with anesthesia \\< 10 mm/5min\n* Patients with Sjögren Syndrome\n\nExclusion Criteria:\n\n* Any concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications at the time of entry into the study\n* Use of contact lenses during the study\n* Significant Eye diseases according to investigator's opinion"}, 'identificationModule': {'nctId': 'NCT04819269', 'briefTitle': "Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome", 'organization': {'class': 'INDUSTRY', 'fullName': 'Sylentis, S.A.'}, 'officialTitle': "Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome", 'orgStudyIdInfo': {'id': 'SYL1001_V'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tivanisiran sodium ophthalmic solution', 'interventionNames': ['Drug: Tivanisiran sodium ophthalmic solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle ophthalmic solution', 'interventionNames': ['Drug: Vehicle ophthalmic solution']}], 'interventions': [{'name': 'Tivanisiran sodium ophthalmic solution', 'type': 'DRUG', 'description': '1 drop in the affected eye(s) once daily', 'armGroupLabels': ['Tivanisiran sodium ophthalmic solution']}, {'name': 'Vehicle ophthalmic solution', 'type': 'DRUG', 'description': '1 drop in the affected eye(s) once daily', 'armGroupLabels': ['Vehicle ophthalmic solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Sylentis Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36301', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Sylentis Investigative Site', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '85254', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sylentis Investigative Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92843', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Sylentis Investigative Site', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Sylentis Investigative Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '90013', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Sylentis Investigative Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Sylentis Investigative Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '95670', 'city': 'Rancho Cordova', 'state': 'California', 'country': 'United States', 'facility': 'Sylentis Investigative Site', 'geoPoint': 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