Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-02-22 @ 9:04 AM
Study NCT ID:
NCT02062905
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dmulani@ocutx.com', 'phone': '781-357-4000', 'title': 'Director, Clinical Affairs', 'organization': 'Ocular Therapeutix, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'OTX-DP Treatment', 'description': 'OTX-DP (sustained release dexamethasone, 0.4 mg)\n\nOTX-DP treatment', 'otherNumAtRisk': 31, 'otherNumAffected': 1, 'seriousNumAtRisk': 31, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo Plug Delivery Vehicle', 'description': 'Placebo Plug with no drug\n\nPlacebo Plug with no drug', 'otherNumAtRisk': 33, 'otherNumAffected': 2, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders'}], 'seriousEvents': [{'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OTX-DP Treatment', 'description': 'OTX-DP (sustained release dexamethasone, 0.4 mg)\n\nOTX-DP treatment'}, {'id': 'OG001', 'title': 'Placebo Plug Delivery Vehicle', 'description': 'Placebo Plug with no drug\n\nPlacebo Plug with no drug'}], 'classes': [{'title': '3 min (14 days post-insertion)', 'categories': [{'measurements': [{'value': '1.80', 'spread': '1.068', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '0.823', 'groupId': 'OG001'}]}]}, {'title': '5 min. (14 days post-insertion)', 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.998', 'groupId': 'OG000'}, {'value': '2.70', 'spread': '0.865', 'groupId': 'OG001'}]}]}, {'title': '7 min. (14 days post-insertion)', 'categories': [{'measurements': [{'value': '1.65', 'spread': '0.989', 'groupId': 'OG000'}, {'value': '2.53', 'spread': '0.880', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days post insertion', 'description': 'Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching)', 'unitOfMeasure': 'units on a scale (0 -4)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Conjunctival Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OTX-DP Treatment', 'description': 'OTX-DP (sustained release dexamethasone, 0.4 mg)\n\nOTX-DP treatment'}, {'id': 'OG001', 'title': 'Placebo Plug Delivery Vehicle', 'description': 'Placebo Plug with no drug\n\nPlacebo Plug with no drug'}], 'classes': [{'title': '7 min. (14 days post-insertion)', 'categories': [{'measurements': [{'value': '1.60', 'spread': '0.753', 'groupId': 'OG000'}, {'value': '2.11', 'spread': '0.727', 'groupId': 'OG001'}]}]}, {'title': '15 min. (14 days post-insertion)', 'categories': [{'measurements': [{'value': '1.53', 'spread': '0.753', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '0.708', 'groupId': 'OG001'}]}]}, {'title': '20 min. (14 days post-insertion)', 'categories': [{'measurements': [{'value': '1.54', 'spread': '0.739', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '0.696', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days post insertion', 'description': 'Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness)', 'unitOfMeasure': 'units on a scale (0 - 4)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OTX-DP Treatment', 'description': 'OTX-DP (sustained release dexamethasone, 0.4 mg)\n\nOTX-DP treatment'}, {'id': 'FG001', 'title': 'Placebo Plug Delivery Vehicle', 'description': 'Placebo Plug with no drug\n\nPlacebo Plug with no drug'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OTX-DP Treatment', 'description': 'OTX-DP (sustained release dexamethasone, 0.4 mg)\n\nOTX-DP treatment'}, {'id': 'BG001', 'title': 'Placebo Plug Delivery Vehicle', 'description': 'Placebo Plug with no drug\n\nPlacebo Plug with no drug'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-28', 'studyFirstSubmitDate': '2014-02-11', 'resultsFirstSubmitDate': '2016-02-29', 'studyFirstSubmitQcDate': '2014-02-12', 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-04-05', 'studyFirstPostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Itching', 'timeFrame': '14 days post insertion', 'description': 'Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching)'}], 'secondaryOutcomes': [{'measure': 'Conjunctival Redness', 'timeFrame': '14 days post insertion', 'description': 'Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness)'}]}, 'conditionsModule': {'conditions': ['Chronic Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen\n* Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation\n\nExclusion Criteria:\n\n* History of ocular surgical intervention within the past 3 months\n* Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit\n* Use any of the following disallowed medications during the period indicated'}, 'identificationModule': {'nctId': 'NCT02062905', 'briefTitle': 'OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ocular Therapeutix, Inc.'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 2 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC™)', 'orgStudyIdInfo': {'id': 'OTX-14-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OTX-DP', 'description': 'OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PV', 'description': 'PV (placebo drug delivery vehicle)', 'interventionNames': ['Other: Placebo Vehicle']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'armGroupLabels': ['OTX-DP']}, {'name': 'Placebo Vehicle', 'type': 'OTHER', 'armGroupLabels': ['PV']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ocular Therapeutix, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ORA, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}