Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-02-01 @ 10:11 PM
Study NCT ID:
NCT04126057
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2019-10-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Myopia Assessment of Two Manufacturing Processes
Sponsor:
Organization:
Raw JSON
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to test vs control, left eyes and right eyes', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DOT Spectacle Lenses Using Control', 'description': 'Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B\n\nSightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '4.65'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Axial Length Progression From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DOT Spectacle Lenses Using Test', 'description': 'Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A\n\nSightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes'}, {'id': 'OG001', 'title': 'DOT Spectacle Lenses Using Control', 'description': 'Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B\n\nSightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes'}], 'classes': [{'categories': [{'measurements': [{'value': '0.046', 'spread': '0.139', 'groupId': 'OG000'}, {'value': '0.047', 'spread': '0.128', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in axial length progression over time between DOT spectacle lenses manufactured by method A versus method B Axial length progression is defined as an axial length elongation that is attributable to myopia.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DOT Spectacle Lenses Test', 'description': 'Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A\n\nSightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes'}, {'id': 'FG001', 'title': 'DOT Spectacle Lenses Control', 'description': 'Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B\n\nSightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '50', 'numSubjects': '50'}, {'groupId': 'FG001', 'numUnits': '50', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '47', 'numSubjects': '47'}, {'groupId': 'FG001', 'numUnits': '46', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '3'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '4'}]}]}], 'typeUnitsAnalyzed': 'Eyes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DOT Spectacle Lenses Test', 'description': 'Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A\n\nSightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes'}, {'id': 'BG001', 'title': 'DOT Spectacle Lenses Control', 'description': 'Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B\n\nSightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.67', 'spread': '2.073', 'groupId': 'BG000'}, {'value': '11.67', 'spread': '2.073', 'groupId': 'BG001'}, {'value': '11.67', 'spread': '2.073', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', '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': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', '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_UNITS', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Eyes'}], 'typeUnitsAnalyzed': 'Eyes', 'populationDescription': 'This was a contralateral eye study of 50 participants in which both eyes were enrolled. In the analysis set, each group has 43 eyes with a total of 43 participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-05', 'size': 6836953, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-03T15:45', 'hasProtocol': True}, {'date': '2020-08-05', 'size': 208440, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-29T10:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-30', 'studyFirstSubmitDate': '2019-10-10', 'resultsFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2019-10-11', 'lastUpdatePostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-30', 'studyFirstPostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Axial Length Progression From Baseline', 'timeFrame': '6 months', 'description': 'Change in axial length progression over time between DOT spectacle lenses manufactured by method A versus method B Axial length progression is defined as an axial length elongation that is attributable to myopia.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Myopia'], 'conditions': ['Juvenile Myopia']}, 'descriptionModule': {'briefSummary': 'Randomized, controlled, multisite, subject- and observer-masked, contralateral clinical trial of 6-month duration to compare two SightGlass Vision Diffusion Optics Technology (DOT) spectacle lens manufacturing processes in reducing the progression of juvenile myopia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children between the ages of 6 and 14 years old (inclusive) with myopia\n* Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye\n* Difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 0.75 D\n\nExclusion Criteria:\n\n* Current use of any myopia control treatment such as atropine, multifocal contact lenses, or orthokeratology (NOTE: Prior bilateral usage acceptable as long as treatment stopped at least 6 months before screening visit. Any subject with a history of unilateral myopia control treatment is excluded.)\n* Any ocular or systemic conditions that could influence refractive development or status \\[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)"}, 'identificationModule': {'nctId': 'NCT04126057', 'acronym': 'MAPLE', 'briefTitle': 'Myopia Assessment of Two Manufacturing Processes', 'organization': {'class': 'INDUSTRY', 'fullName': 'SightGlass Vision, Inc.'}, 'officialTitle': 'Myopia Assessment of Two Manufacturing Processes for Myopia Management Lenses (MAPLE)', 'orgStudyIdInfo': {'id': 'CPRO-1908-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DOT Spectacle Lenses using Manufacturing Method A', 'description': 'Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A', 'interventionNames': ['Device: SightGlass Vision DOT Spectacle Lenses']}, {'type': 'EXPERIMENTAL', 'label': 'DOT Spectacle Lenses using Manufacturing Method B', 'description': 'Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B', 'interventionNames': ['Device: SightGlass Vision DOT Spectacle Lenses']}], 'interventions': [{'name': 'SightGlass Vision DOT Spectacle Lenses', 'type': 'DEVICE', 'otherNames': ['SightGlass Vision'], 'description': 'Subjects randomized to test vs control, left eyes and right eyes', 'armGroupLabels': ['DOT Spectacle Lenses using Manufacturing Method A', 'DOT Spectacle Lenses using Manufacturing Method B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32779', 'city': 'Longwood', 'state': 'Florida', 'country': 'United States', 'facility': 'Sabal Eye Care', 'geoPoint': {'lat': 28.70305, 'lon': -81.3384}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kannarr Eye Care', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '64133', 'city': 'Raytown', 'state': 'Missouri', 'country': 'United States', 'facility': 'Advanced Eyecare PC', 'geoPoint': {'lat': 39.00862, 'lon': -94.46356}}, {'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY School of Optometry', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'William J Bogus, OD, FAAO', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Joseph Rappon, OD, MS, FAAO', 'role': 'STUDY_CHAIR', 'affiliation': 'SightGlass Vision, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SightGlass Vision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}