Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 7:06 PM
Study NCT ID:
NCT05147233
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2021-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@oculis.com', 'phone': '+41 21 711 3970', 'title': 'Sharon Klier, M.D., M.S., M.P.H, Chief Development Officer', 'organization': 'OCULIS Operations SàrI'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose until Day 90', 'eventGroups': [{'id': 'EG000', 'title': 'OCS-01', 'description': '1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 2, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle', 'description': '1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.', 'otherNumAtRisk': 122, 'deathsNumAtRisk': 122, 'otherNumAffected': 8, 'seriousNumAtRisk': 122, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Eye Pain', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'seriousEvents': [{'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absence of Anterior Chamber Cells at Visit 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}, {'units': 'study eye', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OCS-01', 'description': '1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': '1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.2', 'ciLowerLimit': '21.5', 'ciUpperLimit': '44.9', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'unitOfMeasure': 'percentage of study eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'study eye', 'denomUnitsSelected': 'study eye', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Absence of Ocular Pain at Visit 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}, {'units': 'study eye', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OCS-01', 'description': '1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': '1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.5', 'groupId': 'OG000'}, {'value': '52.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.5', 'ciLowerLimit': '11.7', 'ciUpperLimit': '35.3', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 4', 'unitOfMeasure': 'percentage of study eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'study eye', 'denomUnitsSelected': 'study eye', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OCS-01', 'description': '1 drop of OCS-01 in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye.'}, {'id': 'FG001', 'title': 'Vehicle', 'description': '1 drop of vehicle in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OCS-01', 'description': '1 drop of OCS-01 in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye.'}, {'id': 'BG001', 'title': 'Vehicle', 'description': '1 drop of vehicle in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'spread': '7.80', 'groupId': 'BG000'}, {'value': '67.8', 'spread': '8.98', 'groupId': 'BG001'}, {'value': '68.3', 'spread': '8.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', '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': '17', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '186', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set (FAS) consists of all randomized subjects who were analyzed under the treatment to which they were randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-10', 'size': 10691005, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-24T12:36', 'hasProtocol': True}, {'date': '2023-07-13', 'size': 2833747, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-24T12:37', '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': 241}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2021-11-24', 'resultsFirstSubmitDate': '2025-06-24', 'studyFirstSubmitQcDate': '2021-12-06', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-24', 'studyFirstPostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence of Anterior Chamber Cells at Visit 6.', 'timeFrame': 'Day 15'}, {'measure': 'Absence of Ocular Pain at Visit 4.', 'timeFrame': 'Day 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammation Eye Pain', 'Postoperative Cataract']}, 'descriptionModule': {'briefSummary': 'This was a randomized, double-masked, vehicle-controlled, Phase 3 study evaluating the efficacy and safety of OCS-01 QD compared to vehicle in the treatment of inflammation and pain following cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye.\n* Have a pin-hole visual acuity (VA) without any other correction \\> 20 letters (approximately 20/400) in the operative eye and \\> 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 \\[prior to surgery\\]).\n\nExclusion Criteria:\n\n* Have any intraocular inflammation (e.g. white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 \\[prior to surgery\\]) slit lamp examination.\n* Have a score \\> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \\[prior to surgery\\]) in the study eye.'}, 'identificationModule': {'nctId': 'NCT05147233', 'acronym': 'OPTIMIZE-1', 'briefTitle': 'A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oculis'}, 'officialTitle': 'A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle in the Treatment of Inflammation and Pain Following Cataract Surgery', 'orgStudyIdInfo': {'id': 'DX218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OCS-01', 'description': '1 drop of OCS-01 (Dexamethasone ophthalmic suspension 1.5% \\[15 mg/mL\\]) in the study eye once daily (QD) for 14 days, beginning 1-day post-surgery in the study eye.', 'interventionNames': ['Drug: OCS-01']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': '1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'OCS-01', 'type': 'DRUG', 'description': 'Dexamethasone ophthalmic suspension, 1.5%', 'armGroupLabels': ['OCS-01']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'Vehicle', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Oculis Site 16', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85003', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Oculis Site 28', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72704', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Oculis Site 8', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'Oculis Site 9', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Oculis Site 23', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94954', 'city': 'Petaluma', 'state': 'California', 'country': 'United States', 'facility': 'Oculis Site 26', 'geoPoint': {'lat': 38.23242, 'lon': -122.63665}}, {'zip': '90731', 'city': 'San Pedro', 'state': 'California', 'country': 'United States', 'facility': 'Oculis Site 24', 'geoPoint': {'lat': 33.73585, 'lon': -118.29229}}, {'zip': '92683', 'city': 'Westminster', 'state': 'California', 'country': 'United States', 'facility': 'Oculis Site 22', 'geoPoint': {'lat': 33.75918, 'lon': -118.00673}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Oculis Site 11', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': 'Oculis Site 12', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '30260', 'city': 'Morrow', 'state': 'Georgia', 'country': 'United States', 'facility': 'Oculis Site 17', 'geoPoint': {'lat': 33.58317, 'lon': -84.33937}}, {'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Oculis Site 20', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Oculis Site 5', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63090', 'city': 'Washington', 'state': 'Missouri', 'country': 'United States', 'facility': 'Oculis Site 3', 'geoPoint': {'lat': 38.55811, 'lon': -91.01209}}, {'zip': '28501', 'city': 'Kinston', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Oculis Site 13', 'geoPoint': {'lat': 35.26266, 'lon': -77.58164}}, {'zip': '44141', 'city': 'Brecksville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Oculis Site 6', 'geoPoint': {'lat': 41.31978, 'lon': -81.62679}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Oculis Site 14', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oculis Site 25', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '18704', 'city': 'Kingston', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Oculis Site 7', 'geoPoint': {'lat': 41.26175, 'lon': -75.89686}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Oculis Site 4', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Oculis Site 10', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Oculis Site 2', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Oculis Site 31', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84032', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Oculis Site 27', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '24502', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Oculis Site 30', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oculis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}