Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-28 @ 11:50 PM
Study NCT ID:
NCT05501860
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2022-08-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D002355', 'term': 'Carticaine'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mwidmann@calclinicalsolutions.com', 'phone': '919-600-1819', 'title': 'Michelle Widmann', 'organization': 'American Genomics, LLC'}, 'certainAgreement': {'otherDetails': 'Investigative site, the Principal Investigator, and any other investigators understand and agree that the Study is a multi-center clinical study and that a multicenter publication may be prepared and published by the Sponsor. The investigative site and its investigators will not, individually or together, present or publish any findings, data or results of the Study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported starting from the time of signing the informed consent until the end of the study assessment (follow up phone call at day 2-5 or day 90 for specular microscopy subjects).', 'eventGroups': [{'id': 'EG000', 'title': 'AG-920', 'description': 'Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.\n\nAG-920: AG-920 Sterile Topical Ophthalmic Solution', 'otherNumAtRisk': 166, 'deathsNumAtRisk': 166, 'otherNumAffected': 38, 'seriousNumAtRisk': 166, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo Sterile Topical Ophthalmic Solution\n\nPlacebo: Placebo Sterile Topical Ophthalmic Solution', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 10, 'seriousNumAtRisk': 83, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Instillation site pain', 'notes': 'General disorders and administration site conditions - Instillation site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AG-920', 'description': 'Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.\n\nAG-920: AG-920 Sterile Topical Ophthalmic Solution'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Sterile Topical Ophthalmic Solution\n\nPlacebo: Placebo Sterile Topical Ophthalmic Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 (treatment day) to 4 days following treatment day; 90 days following treatment for subjects participating in specular microscopy.', 'description': 'TEAEs will be summarized by treatment group using frequency and percent for each system, organ, class (SOC) and preferred term within each SOC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population is defined as all subjects which were randomized and who received at least one drop of the dose (2 drops) of the study medication. The ITT population is defined as all subjects who were randomized to treatment and have received at least one dose (two drops) of the study medication. In this study, the ITT and safety populations were found to be identical.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Corneal Endothelial Cell Density After Treatment With AG-920', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AG-920', 'description': 'Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.\n\nAG-920: AG-920 Sterile Topical Ophthalmic Solution'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Sterile Topical Ophthalmic Solution\n\nPlacebo: Placebo Sterile Topical Ophthalmic Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.83', 'spread': '92.18', 'groupId': 'OG000'}, {'value': '-44.33', 'spread': '85.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 (treatment day) to 90 days following treatment', 'description': 'Endothelial cell count (and corneal morphology) will be summarized by continuous summaries', 'unitOfMeasure': 'cells/mm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AG-920', 'description': 'Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.\n\nAG-920: AG-920 Sterile Topical Ophthalmic Solution'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo Sterile Topical Ophthalmic Solution\n\nPlacebo: Placebo Sterile Topical Ophthalmic Solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'Specular Microscopy Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Studied Period: 30 July 2022 to 7 December 2022 @ two study centers in the US.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AG-920', 'description': 'Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.\n\nAG-920: AG-920 Sterile Topical Ophthalmic Solution'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo Sterile Topical Ophthalmic Solution\n\nPlacebo: Placebo Sterile Topical Ophthalmic Solution'}, {'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': '149', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.4', 'spread': '16.3', 'groupId': 'BG000'}, {'value': '40.1', 'spread': '15.8', 'groupId': 'BG001'}, {'value': '39.6', 'spread': '16.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Study Eye', 'classes': [{'categories': [{'title': 'Left Eye (OS)', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'Right Eye (OD)', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Color of Iris', 'classes': [{'categories': [{'title': 'Blue', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Brown', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}, {'title': 'Green', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Hazel', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BCVA LogMar', 'classes': [{'title': 'BCVA LogMar Study Eye', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'BG002'}]}]}, {'title': 'BCVA LogMar Fellow Eye', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'LogMar', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-21', 'size': 2513062, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-23T13:32', 'hasProtocol': True}, {'date': '2023-05-16', 'size': 1989046, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-23T13:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The study is double masked.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 2:1 ratio to receive a single dose of AG-920 or placebo into one (study) eye (2 drops 30 seconds apart).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-13', 'studyFirstSubmitDate': '2022-08-12', 'resultsFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2022-08-12', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-13', 'studyFirstPostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From Day 1 (treatment day) to 4 days following treatment day; 90 days following treatment for subjects participating in specular microscopy.', 'description': 'TEAEs will be summarized by treatment group using frequency and percent for each system, organ, class (SOC) and preferred term within each SOC.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Corneal Endothelial Cell Density After Treatment With AG-920', 'timeFrame': 'From Day 1 (treatment day) to 90 days following treatment', 'description': 'Endothelial cell count (and corneal morphology) will be summarized by continuous summaries'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AG-920', 'Articaine', 'Septocaine'], 'conditions': ['Anesthesia, Local']}, 'descriptionModule': {'briefSummary': 'A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects. It is designed to evaluate the ocular safety of a single topical ocular administration of AG-920 sterile topical ophthalmic solution compared to placebo..', 'detailedDescription': 'A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects performed in the US. It is designed to evaluate the ocular safety of one dose of AG-920 compared to placebo. I). In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 2:1 ratio to receive one dose of AG-920 or identical looking placebo into one (study) eye. A subset of subjects will undergo endothelial cell count (ECC) evaluations.\n\nEach dose of AG-920 or placebo will consist of two drops in the study eye. After the completion of dosing, subjects will undergo a series of eye exams that will be documented. Investigational medicinal product (IMP) dosing will be performed by the study staff.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provide written informed consent prior to any study-related procedures being performed.\n2. Male or a non-pregnant, non-lactating female.\n3. Healthy by clinical assessment, including ocular examination.\n4. Have an Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) of 20/200 or better in both eyes.\n5. Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.\n\n Specular microscopy subset subjects only:\n6. Have a central corneal endothelial cell density of ā„1500 cells/mm2 at baseline\n\nExclusion Criteria:\n\n1. . Have participated in an investigational study within the past 30 days.\n2. Have a contraindication to local anesthetics, SeptocaineĀ®, or any component of the IMP.\n3. Have had ocular surgery or general surgery in either eye within the past 90 days.\n4. Have had an intravitreal injection in either eye within 14 days of randomization.\n5. Have ocular surface disease requiring punctal plugs.\n6. Have evidence of any current ocular inflammation.\n7. Current ocular allergy symptoms.\n8. Have used topical, ocular medications in the 24 hours preceding dosing.\n9. Systemic opioid, opiate analgesic or topical Non-steroidal Anti-Inflammatory Drug (NSAID) use within the past 30 days.\n10. Previous participation in a clinical study of AG-920.\n11. A current condition which could cause vision problems such as Pseudotumor Cerebri.'}, 'identificationModule': {'nctId': 'NCT05501860', 'briefTitle': 'A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution', 'organization': {'class': 'INDUSTRY', 'fullName': 'American Genomics, LLC'}, 'officialTitle': 'A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Evaluation of the Ocular Safety of Articaine Sterile Topical Ophthalmic Solution', 'orgStudyIdInfo': {'id': 'AG-920-CS303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AG-920', 'description': 'Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.', 'interventionNames': ['Drug: AG-920']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Sterile Topical Ophthalmic Solution', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AG-920', 'type': 'DRUG', 'otherNames': ['articaine'], 'description': 'AG-920 Sterile Topical Ophthalmic Solution', 'armGroupLabels': ['AG-920']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Sterile Topical Ophthalmic Solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'American Genomics Site 1', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '78503', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'American Genomics Site 2', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}], 'overallOfficials': [{'name': 'Martin Uram, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Expert'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Genomics, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}