Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-04 @ 1:33 PM
Study NCT ID:
NCT06493604
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2024-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Assess the Safety and Efficacy of Subjects With 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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-19', 'size': 4753616, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-12-09T14:38', 'hasProtocol': True}, {'date': '2024-06-20', 'size': 346221, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-12-09T15:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'dispFirstSubmitDate': '2025-12-17', 'completionDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2024-07-02', 'studyFirstSubmitQcDate': '2024-07-02', 'dispFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 1 and Visit 3', 'timeFrame': 'Day -14 to Day 2', 'description': 'Measured using a 0 - 100 visual analog scale (VAS) where 0 is "no discomfort" and 100 is "maximal discomfort"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['reproxalap'], 'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease', 'detailedDescription': 'Dry eye chamber challenge trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age (either gender and any race)\n* Ability to provide written informed consent and sign the Health Information Portability and Accountability Act form\n* Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1\n* Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1\n\nExclusion Criteria:\n\n* Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters\n* Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1\n* Contact lens use within 7 days of Visit 1 or anticipated use of contact lenses during the trial\n* Previous laser-assisted in situ keratomileusis surgery within the last 12 months\n* Systemic corticosteroid or other immunomodulator therapy (not including inhaled corticosteroids) within 14 days of Visit 1, or any planned immunomodulatory therapy throughout the clinical trial\n* Use of and unwillingness to discontinue topical ophthalmic prescriptions (including medications for glaucoma) or over-the-counter solutions (not including artificial tears), gels, or scrubs for the duration of the trial (excluding medications allowed for the conduct of the trial)'}, 'identificationModule': {'nctId': 'NCT06493604', 'briefTitle': 'A Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aldeyra Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease', 'orgStudyIdInfo': {'id': 'ADX-102-DED-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days', 'interventionNames': ['Drug: Reproxalap Ophthalmic Solution (0.25%)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Ophthalmic Solution administered six times over two consecutive days', 'interventionNames': ['Drug: Vehicle Ophthalmic Solution']}], 'interventions': [{'name': 'Reproxalap Ophthalmic Solution (0.25%)', 'type': 'DRUG', 'description': 'Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days', 'armGroupLabels': ['Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days']}, {'name': 'Vehicle Ophthalmic Solution', 'type': 'DRUG', 'description': 'Vehicle Ophthalmic Solution administered six times over two consecutive days', 'armGroupLabels': ['Vehicle Ophthalmic Solution administered six times over two consecutive days']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aldeyra Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}