Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-04 @ 4:38 PM
Study NCT ID:
NCT06400459
Status:
COMPLETED
Last Update Posted:
2024-10-18
First Post:
2024-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-23', 'mcpReleaseN': 4, 'releaseDate': '2025-10-10'}, {'resetDate': '2025-11-06', 'mcpReleaseN': 5, 'releaseDate': '2025-10-24'}, {'resetDate': '2025-11-25', 'mcpReleaseN': 6, 'releaseDate': '2025-11-14'}], 'estimatedResultsFirstSubmitDate': '2025-10-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-masked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-masked'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2024-05-01', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Schirmer's", 'timeFrame': '29 Days', 'description': 'Mean change from baseline in study eye in unanesthetized Schirmer'}], 'secondaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '29 Days', 'description': 'Mean change from baseline in best corrected visual acuity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'Double-masked, dose-response, trial of IVW-1001 in subjects with dry eye disease.', 'detailedDescription': 'This is a randomized (1:1:1), multicenter, parallel, vehicle-controlled, double-masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipes in subjects with DED. Treatments will be IVW-1001 Ophthalmic Eyelid Wipe 0.2% (high dose), IVW 1001 0.1% (low dose), or IVW-1001 Ophthalmic Eyelid Wipe Placebo (vehicle). Subjects will participate in a 7-day, run-in period followed by a 28-daydosing period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects of any gender at least 18 years of age at the Screening Visit\n2. Able to voluntarily provide written informed consent to participate in the study\n3. Able and willing to comply with all study procedures and restrictions, follow study instructions, and complete required study visits\n4. Diagnosis of Dry Eye Disease (DED)\n\nExclusion Criteria:\n\n1. Corneal fluorescein staining score of 4 using the NEI grading system\n2. Intraocular pressure ≥23 mmHg\n3. History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention\n4. Subjects with ocular inflammatory conditions (eg, conjunctivitis, keratitis, severe anterior blepharitis, etc.) not related to DED'}, 'identificationModule': {'nctId': 'NCT06400459', 'briefTitle': 'IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'IVIEW Therapeutics Inc.'}, 'officialTitle': 'Phase 1/2a, Proof-of-Concept, Multicenter, Parallel, Vehicle-Controlled, Double-Masked, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of IVW-1001 Ophthalmic Eyelid Wipe in Subjects With Dry Eye Disease', 'orgStudyIdInfo': {'id': 'IVW-1001-CS-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IVW-1001 0.1%', 'description': 'IVW-1001 Ophthalmic Eyelid Wipe 0.1%', 'interventionNames': ['Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.1%']}, {'type': 'EXPERIMENTAL', 'label': 'IVW-1001 0.2%', 'description': 'IVW-1001 Ophthalmic Eyelid Wipe 0.1%', 'interventionNames': ['Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'IVW-1001 Placebo', 'description': 'Vehicle', 'interventionNames': ['Drug: IVW-1001 Placebo']}], 'interventions': [{'name': 'IVW-1001 Ophthalmic Eyelid Wipe 0.1%', 'type': 'DRUG', 'description': 'IVW-1001 Ophthalmic Eyelid Wipe 0.1%', 'armGroupLabels': ['IVW-1001 0.1%']}, {'name': 'IVW-1001 Ophthalmic Eyelid Wipe 0.2%', 'type': 'DRUG', 'description': 'IVW-1001 Ophthalmic Eyelid Wipe 0.2%', 'armGroupLabels': ['IVW-1001 0.2%']}, {'name': 'IVW-1001 Placebo', 'type': 'DRUG', 'description': 'IVW-1001 Placebo', 'armGroupLabels': ['IVW-1001 Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Eye Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Bo Liang, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IVIEW Therapeutics Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IVIEW Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}