Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-28 @ 2:15 PM
Study NCT ID:
NCT05814757
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2023-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D005128', 'term': 'Eye Diseases'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070635', 'term': 'Punctal Plugs'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double (Participant, Masked Investigator)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel: Participants are assigned to one of three groups in parallel for the duration of the study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2023-03-24', 'studyFirstSubmitQcDate': '2023-04-12', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of Eye Dryness Score (visual analogue scale (VAS))', 'timeFrame': 'Change from baseline (CFB) at Day 15', 'description': 'Visual Analogue Scale (0 mm - no discomfort to 100mm - maximal (the most) discomfort)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndromes', 'Eye Diseases']}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of OTX-DED for the short-term treatment of the symptoms of DED', 'detailedDescription': 'Randomized, double-masked, study to evaluate the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of the symptoms of dry eye disease (DED). The subjects will be followed for approximately two months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* VAS eye dryness severity score ≥ 35 and ≤ 90 at screening.\n* Investigator assessment of bulbar conjunctival hyperemia grade ≥ 2 (CCLRU; 0 - 4 scale).\n* Unanesthetized Schirmer of \\> 0 and ≤ 10 mm.\n* Must not have used Artificial Tears during the Screening period.\n* IOP in both eyes ≥ 5 mmHg and ≤21 mmHg.\n\nExclusion Criteria:\n\n* Have worn contact lenses in the 4 weeks prior to the screening visit and/or are unwilling to discontinue use of contact lenses throughout the study period.\n* Have a history of glaucoma or ocular hypertension or have a history of intraocular pressure (IOP) \\< 5 mmHg or \\> 24 mmHg.'}, 'identificationModule': {'nctId': 'NCT05814757', 'briefTitle': 'OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ocular Therapeutix, Inc.'}, 'officialTitle': 'A Randomized, Double-masked, Study to Evaluate the Efficacy and Safety of OTX-DED (Dexamethasone Intracanalicular Ophthalmic Insert) for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)', 'orgStudyIdInfo': {'id': 'OTX-DED-2022-C01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OTX-DED 0.3mg', 'interventionNames': ['Drug: OTX-DED']}, {'type': 'EXPERIMENTAL', 'label': 'Controlled Insertion utilizing Collagen Punctal Plug', 'interventionNames': ['Drug: Controlled Insertion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Collagen Punctal Plug (Full Insertion)', 'interventionNames': ['Drug: Collagen Punctal Plug']}], 'interventions': [{'name': 'OTX-DED', 'type': 'DRUG', 'description': '0.3mg dexamethasone ophthalmic insert', 'armGroupLabels': ['OTX-DED 0.3mg']}, {'name': 'Controlled Insertion', 'type': 'DRUG', 'description': 'Collagen Punctal Plug 0.2mm (Controlled Insertion)', 'armGroupLabels': ['Controlled Insertion utilizing Collagen Punctal Plug']}, {'name': 'Collagen Punctal Plug', 'type': 'DRUG', 'description': 'Collagen Punctal Plug 0.2mm (Full Insertion)', 'armGroupLabels': ['Collagen Punctal Plug (Full Insertion)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Ocular Therapeutix', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ocular Therapeutix, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}