Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT06360133
Status:
RECRUITING
Last Update Posted:
2024-11-20
First Post:
2024-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, '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': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-17', 'studyFirstSubmitDate': '2024-04-06', 'studyFirstSubmitQcDate': '2024-04-06', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal Fluorescein Staining', 'timeFrame': 'Day 84', 'description': 'Mean Change from baseline (Visit 2) to Day84 (Visit 6) in total corneal fluorescein staining (tCFS) using modified NEI/Industry Workshop (0-4 scale, using 0.5 unit increments).'}], 'secondaryOutcomes': [{'measure': 'Eye Dryness', 'timeFrame': 'Day 84', 'description': 'Mean Change from baseline (Visit 2) to Day 84 (Visit 6) in the individual symptom of eye dryness (0\\~100 VAS scale).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'This is a Phase 3, randomized, double-Masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% VVN001 Ophthalmic Solution versus vehicle in Chinese subjects with dry eye disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provided written informed consent prior to any study-related procedures.\n* Are between 30 and 80 years of age.\n* Have a history of dry eye disease in both eyes.\n* Have been using artificial tears within 30 days of the screening visit\n* Have an Eye dryness score ≥50 (0-100 point VAS)\n* Have ongoing dry eye disease in the same eye or both eyes, as defined by all of the following criteria in the study eye and the same eye at Visit 1 and Visit 2: 1) total CFS (tCFS) score ≥6; 2) any subregion CS score ≥2.5; 3) Schirmer score (without anesthesia) ≥1 and ≤7 mm/5 min.\n* Have a BCVA in the study eye of ≥4.3 (Standard for Logarithmic Visual Acuity Charts, 5-mark record).\n\nExclusion Criteria:\n\n* Have a known hypersensitivity or contraindication to the IP or components of IP.\n* Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. Or the subject has had laser or surgery for glaucoma in the study eye within 90 days of the study.\n* Woman of childbearing potential (WOCP) who are pregnant, lactating, or preparing for pregnant.'}, 'identificationModule': {'nctId': 'NCT06360133', 'briefTitle': 'Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'VivaVision Biotech, Inc'}, 'officialTitle': 'A Phase 3, Randomized, Double-Masked, Vehicle-controlled, Multi-center Study Evaluating the Safety and Efficacy of 5% VVN001 in Chinese Subjects With Dry Eye Disease', 'orgStudyIdInfo': {'id': 'VVN001-CCS-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VVN001', 'description': 'VVN001 Ophthalmic Solution, 5%', 'interventionNames': ['Drug: VVN001 Ophthalmic Solution, 5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'VVN001 Ophthalmic Solution, Vehicle', 'interventionNames': ['Drug: VVN001 Ophthalmic Solution, Vehicle']}], 'interventions': [{'name': 'VVN001 Ophthalmic Solution, 5%', 'type': 'DRUG', 'description': 'VVN001 Ophthalmic Solution, 5%', 'armGroupLabels': ['VVN001']}, {'name': 'VVN001 Ophthalmic Solution, Vehicle', 'type': 'DRUG', 'description': 'VVN001 Ophthalmic Solution, Vehicle', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Eye & Ent Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Caroline Lu', 'role': 'CONTACT', 'email': 'caroline.lu@vivavisionbio.com', 'phone': '86-18816562189'}], 'overallOfficials': [{'name': 'Xinghuai Sun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye & ENT Hospital of Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VivaVision Biotech, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}