Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04206020
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2019-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007637', 'term': 'Keratoconjunctivitis'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600714', 'term': 'Visomitin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@mitotechpharma.com', 'phone': '+352621692785', 'title': 'Chief Operating Officer', 'organization': 'Mitotech S.A.'}, 'certainAgreement': {'otherDetails': 'Authorship and manuscript composition will reflect cooperation among all parties involved in the study. Authorship will be established before writing the manuscript. The study sponsor will have the final decision regarding the manuscript and publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Day -7 through end of study (Day 57)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Comparator: SkQ1 Vehicle', 'description': 'Vehicle for SkQ1 Ophthalmic Solution', 'otherNumAtRisk': 306, 'deathsNumAtRisk': 306, 'otherNumAffected': 19, 'seriousNumAtRisk': 306, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'SkQ1 Ophthalmic Solution', 'description': 'SkQ1 Ophthalmic Solution (1.55µg/mL)', 'otherNumAtRisk': 304, 'deathsNumAtRisk': 304, 'otherNumAffected': 20, 'seriousNumAtRisk': 304, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Instillation site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Discomfort Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Comparator: SkQ1 Vehicle', 'description': 'Vehicle for SkQ1 Ophthalmic Solution'}, {'id': 'OG001', 'title': 'SkQ1 Ophthalmic Solution', 'description': 'SkQ1 Ophthalmic Solution (1.55µg/mL)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 57', 'description': 'Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Conjunctival Fluorescein Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Comparator: SkQ1 Vehicle', 'description': 'Vehicle for SkQ1 Ophthalmic Solution'}, {'id': 'OG001', 'title': 'SkQ1 Ophthalmic Solution', 'description': 'SkQ1 Ophthalmic Solution (1.55µg/mL)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.63', 'spread': '1.087', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '1.150', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 57', 'description': 'Change of Conjunctival Fluorescein Staining (sum of temporal and nasal regions), scale in each region ranged from 0 to 4 with 0 = No Staining and 4 = Confluent Staining', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Comparator: SkQ1 Vehicle', 'description': 'Vehicle for SkQ1 Ophthalmic Solution'}, {'id': 'FG001', 'title': 'SkQ1 Ophthalmic Solution', 'description': 'SkQ1 Ophthalmic Solution (1.55µg/mL)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}, {'groupId': 'FG001', 'numSubjects': '304'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}, {'groupId': 'FG001', 'numSubjects': '297'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Unable to attend visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '610', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Comparator: SkQ1 Vehicle', 'description': 'Vehicle for SkQ1 Ophthalmic Solution'}, {'id': 'BG001', 'title': 'SkQ1 Ophthalmic Solution', 'description': 'SkQ1 Ophthalmic Solution (1.55µg/mL)'}, {'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': '166', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Mean (SD)', 'categories': [{'measurements': [{'value': '61.9', 'spread': '11.92', 'groupId': 'BG000'}, {'value': '62.8', 'spread': '12.58', 'groupId': 'BG001'}, {'value': '62.4', 'spread': '12.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '223', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '494', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '306', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '610', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ocular Discomfort Scale', 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.06', 'groupId': 'BG000'}, {'value': '2.7', 'spread': '0.98', 'groupId': 'BG001'}, {'value': '2.7', 'spread': '1.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-04', 'size': 4223881, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-20T16:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment Parallel-group study SkQ1 Ophthalmic Solution versus placebo (vehicle) solution'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 610}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-20', 'studyFirstSubmitDate': '2019-12-18', 'resultsFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2019-12-18', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-20', 'studyFirstPostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Discomfort Scale', 'timeFrame': 'From baseline to Day 57', 'description': 'Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.'}, {'measure': 'Conjunctival Fluorescein Staining', 'timeFrame': 'From baseline to Day 57', 'description': 'Change of Conjunctival Fluorescein Staining (sum of temporal and nasal regions), scale in each region ranged from 0 to 4 with 0 = No Staining and 4 = Confluent Staining'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry Eye', 'Dry Eye Syndrome', 'SkQ1', 'KCS', 'Keratoconjunctivitis'], 'conditions': ['Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether SkQ1 Ophthalmic Solution is safe and effective compared to Vehicle for the treatment of the signs and symptoms of dry eye syndrome.', 'detailedDescription': 'Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over the course of approximately 9 weeks. Qualified subjects are randomized 1:1 to receive either SkQ1 Ophthalmic Solution, or Placebo (vehicle of SkQ1 Ophthalmic Solution).\n\nThe Primary Endpoints are:\n\nChange from Baseline (Visit 2) to Visit 5 of Ocular Discomfort;\n\nChange from Baseline (Visit 2) to Visit 5 of conjunctival fluorescein staining (sum of temporal and nasal regions)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'self-representation', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be at least 18 years of age;\n* Provide written informed consent;\n* Have a subject reported history of dry eye;\n* Have a history of use of eye drops for dry eye symptoms;\n* Ocular Discomfort;\n* Schirmer's Test score;\n* Have corneal fluorescein staining ;\n* Have lissamine green conjunctival Staining;\n* Have a conjunctival redness;\n\nExclusion Criteria:\n\n* Have been previously exposed to previous SkQ1 Ophthalmic Solution treatment;\n* Have any clinically significant slit lamp findings at Visit 1;\n* Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit 1;\n* Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned over the study period;\n* Have an uncontrolled systemic disease;\n* Be a woman who is pregnant, nursing or planning a pregnancy;\n* Be a woman of childbearing potential who is not using an acceptable means of birth control;\n* Have a known allergy and/or sensitivity to the study drug or its components;\n* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;\n* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;"}, 'identificationModule': {'nctId': 'NCT04206020', 'acronym': 'VISTA-2', 'briefTitle': 'Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mitotech, SA'}, 'officialTitle': 'A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study of Safety and Efficacy of SkQ1 Ophthalmic Solution in the Environment and the Controlled Adverse Environmental (CAE®) Model for the Treatment of Dry Eye Syndrome', 'orgStudyIdInfo': {'id': '19-110-0011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator: SkQ1 Vehicle', 'description': 'Vehicle for SkQ1 Ophthalmic Solution', 'interventionNames': ['Drug: SkQ1 Vehicle Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SkQ1', 'description': 'SkQ1 Ophthalmic Solution', 'interventionNames': ['Drug: SkQ1 Ophthalmic Solution']}], 'interventions': [{'name': 'SkQ1 Vehicle Solution', 'type': 'DRUG', 'otherNames': ['Vehicle for SkQ1'], 'description': 'SkQ1 Ophthalmic Solution Vehicle', 'armGroupLabels': ['Placebo Comparator: SkQ1 Vehicle']}, {'name': 'SkQ1 Ophthalmic Solution', 'type': 'DRUG', 'otherNames': ['Visomitin'], 'description': 'SkQ1 Ophthalmic Solution', 'armGroupLabels': ['SkQ1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85375', 'city': 'Sun City West', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Eye Institute and Cosmetic Laser', 'geoPoint': {'lat': 33.66198, 'lon': -112.34127}}, {'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Eye Clinics of South Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '24502', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Piedmont Eye Center', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}], 'overallOfficials': [{'name': 'Lawrence T Friedhoff, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mitotech, SA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mitotech, SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ORA, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}