Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-27 @ 4:09 PM
Study NCT ID:
NCT03312257
Status:
COMPLETED
Last Update Posted:
2022-12-09
First Post:
2017-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bifocal & Atropine in Myopia (BAM) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001285', 'term': 'Atropine'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'walline.1@osu.edu', 'phone': '614-247-6840', 'title': 'Jeffrey Walline', 'organization': 'Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Three years', 'eventGroups': [{'id': 'EG000', 'title': 'Multifocal D +2.50 Add & 0.01% Atropine', 'description': 'The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power; the 0.01% atropine is a low-dose atropine.\n\nMultifocal D +2.50 add \\& 0.01% atropine: Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 46, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mild eye itching at the drops administering site, which resolved within a few minutes per subjects.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 46}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Refractive Error Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Multifocal D +2.50 Add & 0.01% Atropine', 'description': 'The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power; the 0.01% atropine is a low-dose atropine.\n\nMultifocal D +2.50 add \\& 0.01% atropine: Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.50', 'spread': '0.72', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.21', 'statisticalMethod': 'Repeated measures analyses', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Repeated measures analyses using mixed linear models in STATA (version 15) were undertaken to model myopia progression (primary outcome) and axial elongation (secondary outcome) to account for the clusters of correlated data due to repeated participant outcome measures.'}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the combination treatment (+2.50 D add soft bifocal lens and 0.01% atropine) group and the historical control group (+2.50 D add soft bifocal lens only) in the BLINK Study.', 'unitOfMeasure': 'Diopter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Axial Length Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Multifocal D +2.50 Add & 0.01% Atropine', 'description': 'The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power; the 0.01% atropine is a low-dose atropine.\n\nMultifocal D +2.50 add \\& 0.01% atropine: Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'spread': '0.75', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.054', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.002', 'statisticalMethod': 'Repeated measures analyses', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Repeated measures analyses using mixed linear models in STATA (version 15) were undertaken to model myopia progression (primary outcome) and axial elongation (secondary outcome) to account for the clusters of correlated data due to repeated participant outcome measures.'}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the combination treatment (+2.50 D add soft bifocal lens and 0.01% atropine) group and the historical control group (+2.50 D add soft bifocal lens only) in the BLINK Study.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Multifocal D +2.50 Add & 0.01% Atropine', 'description': 'The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power; the 0.01% atropine is a low-dose atropine.\n\nMultifocal D +2.50 add \\& 0.01% atropine: Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Multifocal D +2.50 Add & 0.01% Atropine', 'description': 'The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power; the 0.01% atropine is a low-dose atropine.\n\nMultifocal D +2.50 add \\& 0.01% atropine: Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '1.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-02', 'size': 17860993, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-13T17:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-14', 'studyFirstSubmitDate': '2017-10-12', 'resultsFirstSubmitDate': '2022-10-19', 'studyFirstSubmitQcDate': '2017-10-12', 'lastUpdatePostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-14', 'studyFirstPostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Refractive Error Progression', 'timeFrame': '3 years', 'description': 'Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the combination treatment (+2.50 D add soft bifocal lens and 0.01% atropine) group and the historical control group (+2.50 D add soft bifocal lens only) in the BLINK Study.'}], 'secondaryOutcomes': [{'measure': 'Axial Length Progression', 'timeFrame': '3 years', 'description': 'Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the combination treatment (+2.50 D add soft bifocal lens and 0.01% atropine) group and the historical control group (+2.50 D add soft bifocal lens only) in the BLINK Study.'}]}, 'conditionsModule': {'conditions': ['Refractive Errors']}, 'referencesModule': {'references': [{'pmid': '35511120', 'type': 'DERIVED', 'citation': 'Jones JH, Mutti DO, Jones-Jordan LA, Walline JJ. Effect of Combining 0.01% Atropine with Soft Multifocal Contact Lenses on Myopia Progression in Children. Optom Vis Sci. 2022 May 1;99(5):434-442. doi: 10.1097/OPX.0000000000001884. Epub 2022 Feb 25.'}, {'pmid': '31046016', 'type': 'DERIVED', 'citation': 'Huang J, Mutti DO, Jones-Jordan LA, Walline JJ. Bifocal & Atropine in Myopia Study: Baseline Data and Methods. Optom Vis Sci. 2019 May;96(5):335-344. doi: 10.1097/OPX.0000000000001378.'}]}, 'descriptionModule': {'briefSummary': 'This study will test whether the combined treatment of 0.01% atropine and soft bifocal contact lens wear produces slower myopia progression and axial elongation compared to soft bifocal contact lenses alone in children ages 7 to 11 years old.', 'detailedDescription': 'Both atropine and soft bifocal contact lenses have been shown to slow myopia progression, and both can cause changes in choroidal thickness. But the relationship between these mechanisms is unclear. The central hypothesis to be tested in the BAM Study is that atropine and soft bifocal contact lenses each exert their anti-progression actions through a common pathway that involves the choroid. If this is correct, then adding atropine treatment to soft bifocal contact lens wear will lead to a more effective slowing of myopia progression than prescribing soft bifocal contact lenses alone due to the additive effects in the common pathway.\n\nThe BAM Study is an ancillary study of an NIH sponsored multi-center, randomized clinical trial, the Bifocal Lenses In Nearsighted Kids (BLINK) Study (NIH: U10EY023208; NCT: NCT02255474). The BLINK Study compares myopia progression between subjects who wear single vision contact lenses and those wearing soft bifocal contact lenses. The BAM Study enrolls an additional 49 subjects that are age-matched with the participants who are wearing +2.50D add soft bifocal contact lenses in the BLINK Study. The subjects in the BAM Study wear +2.50D add soft bifocal contact lenses in combination with daily administration of one drop of 0.01% atropine in each eye for three years. The rates of myopia progression and axial elongation will be compared to the rates in participants who are receiving treatment with +2.50D add soft bifocal contact lenses alone in the BLINK Study.\n\nTwo specific aims will be addressed: Aim 1: To test whether the combined treatment of 0.01% atropine and soft bifocal contact lens wear produces slower myopia progression and axial elongation compared to soft bifocal contact lenses alone over 3 years. Aim 2: To test whether early changes in choroidal thickness can be used as predictors of long-term myopia progression / axial elongation. The results of this study will have significant implications for future studies to develop and test new therapeutic regimes that optimize the effect of myopia control through combined pharmacological and optical interventions. The outcomes will also aid in understanding the potential role of short-term changes of choroidal thickness in long- term regulation of myopia progression and ocular growth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 7 to 11 years, inclusive, at baseline examination\n* -0.75 to -5.00 D, inclusive, spherical component, cycloplegic autorefraction\n* ≤1.00 DC, cycloplegic autorefraction\n* ≤ 2.00 D difference between the sphere components of the two eyes (anisometropia), cycloplegic autorefraction\n* 0.1 logMAR or better best-corrected visual acuity in each eye\n* 0.1 logMAR or better visual acuity OU distance and near with a +2.50 D add contact lens\n* +2.50 D add lens provides adequate fit with respect to movement and centration\n* Finish at least 71% of 0.01% atropine during the run-in period\n\nExclusion Criteria:\n\n* Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)\n* Previous intraocular or corneal surgery\n* Systemic disease that may affect vision, vision development, or contact lens wear (eg, diabetes, Down syndrome, etc.)\n* Previous gas permeable, soft bifocal, or orthokeratology contact lens wear or bifocal/PAL spectacle wear (longer than 1 month of wear)\n* Previous or current participation in myopia control studies\n* Chronic use of medications that may affect immunity, such as oral or ophthalmic corticosteroids for ocular or systemic diseases\n* Issues that may interfere with the ability to participate over the next 3 years'}, 'identificationModule': {'nctId': 'NCT03312257', 'acronym': 'BAM', 'briefTitle': 'Bifocal & Atropine in Myopia (BAM) Study', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Myopia Control in Children With Low-dose Atropine and Soft Bifocal Contact Lenses', 'orgStudyIdInfo': {'id': 'K23EY025273', 'link': 'https://reporter.nih.gov/quickSearch/K23EY025273', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multifocal D +2.50 add & 0.01% atropine', 'description': 'The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power; the 0.01% atropine is a low-dose atropine.', 'interventionNames': ['Combination Product: Multifocal D +2.50 add & 0.01% atropine']}], 'interventions': [{'name': 'Multifocal D +2.50 add & 0.01% atropine', 'type': 'COMBINATION_PRODUCT', 'description': 'Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.', 'armGroupLabels': ['Multifocal D +2.50 add & 0.01% atropine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Juan Huang, PhD, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ohio State Univeristy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jenny Jones', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Jenny Jones', 'investigatorAffiliation': 'Ohio State University'}}}}