Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-01-04 @ 10:36 PM
Study NCT ID:
NCT06296966
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-03-05', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Schirmer's Tear Test", 'timeFrame': 'Measured over a 4-week treatment period', 'description': "Schirmer's Tear Test strips are used to measure ocular fluid."}], 'secondaryOutcomes': [{'measure': 'Ocular Staining', 'timeFrame': 'Measured over a 4-week treatment period', 'description': 'Ocular Staining will be assessed by the investigator on a scale of 0-4, with a higher number indicating a higher grade of staining.'}, {'measure': 'Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS)', 'timeFrame': 'Measured over a 4-week treatment period', 'description': 'EDS is reported by the subject using a 100-point scale (0=no discomfort and 100=maximum discomfort).'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be at least 18 years of age of either gender and any race.\n* Provide written informed consent and sign the HIPAA form.\n* Be willing and able to follow all instructions and attend all study visits.\n\nExclusion Criteria:\n\n* Use of any of the disallowed medications during the washout and study period.'}, 'identificationModule': {'nctId': 'NCT06296966', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'A Four-Week, Double-Masked, Randomized, Placebo-Controlled, Phase 2, Evaluation of the Safety and Efficacy of VSJ-110 Ophthalmic Solution in the Treatment of Dry Eye', 'orgStudyIdInfo': {'id': 'VP-VSJ-110-2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VSJ-110 Solution', 'interventionNames': ['Drug: VSJ-110']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Solution', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'VSJ-110', 'type': 'DRUG', 'description': 'ophthalmic solution', 'armGroupLabels': ['VSJ-110 Solution']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'ophthalmic solution', 'armGroupLabels': ['Placebo Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanda Pharmaceuticals Inc.', 'role': 'CONTACT', 'email': 'clinicaltrials@vandapharma.com', 'phone': '202-734-3400'}], 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}], 'centralContacts': [{'name': 'Vanda Pharmaceuticals Inc.', 'role': 'CONTACT', 'email': 'clinicaltrials@vandapharma.com', 'phone': '202-734-3400'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanda Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}