Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT03374306
Status:
COMPLETED
Last Update Posted:
2024-10-16
First Post:
2017-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001285', 'term': 'Atropine'}, {'id': 'D065346', 'term': 'Lubricant Eye Drops'}], 'ancestors': [{'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D054327', 'term': 'Lubricants'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'henryhl.chan@polyu.edu.hk', 'phone': '+85227667937', 'title': 'Prof. Henry Chan', 'organization': 'HK Polytechnic University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '18 months', 'eventGroups': [{'id': 'EG000', 'title': 'Atropine 0.01%', 'description': 'Group receiving atropine treatment for 18 months\n\nAtropine (0.01%): tropical application', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Artifical Tear', 'description': 'Group receiving placebo for 18 months\n\nArtificial tear: tropical application', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annualized Changes in Refractive Error (SER)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atropine 0.01%', 'description': 'Group receiving atropine treatment for 18 months\n\nAtropine (0.01%): tropical application'}, {'id': 'OG001', 'title': 'Artifical Tear', 'description': 'Group receiving placebo for 18 months\n\nArtificial tear: tropical application'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months', 'unitOfMeasure': 'Dioptre/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Annualized changes in refractive error (SER)'}, {'type': 'SECONDARY', 'title': 'Annualized Change in Axial Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atropine 0.01%', 'description': 'Group receiving atropine treatment for 18 months\n\nAtropine (0.01%): tropical application'}, {'id': 'OG001', 'title': 'Artifical Tear', 'description': 'Group receiving placebo for 18 months\n\nArtificial tear: tropical application'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Annualized change in axial length after receiving the 0.01 atropine or artificial tears up to 18 months', 'unitOfMeasure': 'mm/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'annualized change in axial length'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atropine 0.01%', 'description': 'Group receiving atropine treatment for 18 months\n\nAtropine (0.01%): tropical application'}, {'id': 'FG001', 'title': 'Artifical Tear', 'description': 'Group receiving placebo for 18 months\n\nArtificial tear: tropical application'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Recruitment period: Feb 2018 - Oct 2018 Location: HK PolyU Optometry clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Atropine 0.01%', 'description': 'Group receiving atropine treatment for 18 months\n\nAtropine (0.01%): tropical application'}, {'id': 'BG001', 'title': 'Artifical Tear', 'description': 'Group receiving placebo for 18 months\n\nArtificial tear: tropical application'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '61', '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_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '2 subjects from treatment group and 8 subjects from control group withdrew from the study'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '2 subjects from treatment group and 8 subjects from control group withdrew from the study'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hong Kong', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': '2 subjects from treatment group and 8 subjects from control group withdrew from the study'}, {'title': 'Refractive errors', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-1.88', 'spread': '1.08', 'groupId': 'BG000'}, {'value': '-1.74', 'spread': '0.71', 'groupId': 'BG001'}, {'value': '-1.8', 'spread': '0.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Dioptre', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '2 subjects from treatment group and 8 subjects from control group withdrew from the study'}, {'title': 'Electroretinogram', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41.65', 'spread': '24.4', 'groupId': 'BG000'}, {'value': '50.01', 'spread': '27.75', 'groupId': 'BG001'}, {'value': '45.16', 'spread': '25.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Induced response from central retina measured by multifocal electroretinogram', 'unitOfMeasure': 'nV/deg^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '2 subjects from treatment group and 8 subjects from control group withdrew from the study'}, {'title': 'Axial length', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24.17', 'spread': '0.79', 'groupId': 'BG000'}, {'value': '24.09', 'spread': '0.74', 'groupId': 'BG001'}, {'value': '24.13', 'spread': '0.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '2 subjects from treatment group and 8 subjects from control group withdrew from the study'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-01', 'size': 302921, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-10T20:18', 'hasProtocol': True}, {'date': '2018-01-01', 'size': 108791, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-10T20:20', 'hasProtocol': False}, {'date': '2018-02-02', 'size': 167777, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-18T05:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blinded'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2017-12-11', 'resultsFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2017-12-11', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-10', 'studyFirstPostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Changes in Refractive Error (SER)', 'timeFrame': '18 months', 'description': 'Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months'}], 'secondaryOutcomes': [{'measure': 'Annualized Change in Axial Length', 'timeFrame': '18 months', 'description': 'Annualized change in axial length after receiving the 0.01 atropine or artificial tears up to 18 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myopia', 'Myopia control', 'Atropine', 'Electroretinogram', 'Multifocal Electroretinogram'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Our project is a 24-month longitudinal randomized controlled trial that aims to investigate the myopia development after topical application of 0.01% atropine in children with either fast or slow myopia progression classified according to their initial electro-retinal responses. This will help elucidate the effectiveness of using low concentration atropine for myopia control in children with different myopia progression rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 7 and 10 years\n* Good general health and no family history of ocular diseases\n* No current or history of epilepsy or asthma\n* Myopia : -0.50 to -1.00 D (inclusive, both eyes)\n* Astigmatism : ≤ 0.50 D\n* No hyperopia, amblyopia or strabismus\n* No reported ocular eye diseases or disorders\n* No drug allergy'}, 'identificationModule': {'nctId': 'NCT03374306', 'briefTitle': 'Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Treatment Effect of Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate as Classified by Electro-retinal Responses', 'orgStudyIdInfo': {'id': 'HongKongPU_Optometry1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atropine 0.01%', 'description': 'Group receiving atropine treatment for 18 months', 'interventionNames': ['Drug: Atropine (0.01%)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Artifical tear', 'description': 'Group receiving placebo for 18 months', 'interventionNames': ['Drug: Artificial tear']}], 'interventions': [{'name': 'Atropine (0.01%)', 'type': 'DRUG', 'description': 'tropical application', 'armGroupLabels': ['Atropine 0.01%']}, {'name': 'Artificial tear', 'type': 'DRUG', 'description': 'tropical application', 'armGroupLabels': ['Artifical tear']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'School of Optometry, Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Henry HL CHAN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Association Professor', 'investigatorFullName': 'Henry HL Chan, PhD', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}