Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-04 @ 3:22 AM
Study NCT ID:
NCT03506568
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2018-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robertkinast@gmail.com', 'phone': '503-413-8202', 'title': 'Dr. Robert Kinast', 'organization': 'Devers Eye Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 month', 'description': 'The device does not change the level of risk for someone already taking eye drops.', 'eventGroups': [{'id': 'EG000', 'title': 'Control - no Reminder', 'description': 'For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Integrated Daily Reminder Using the D3 App', 'description': 'For Group 2, they will have their D3 app turned on to deliver both a push notification reminder to their smart phone and audio and visual reminders to their D3 device.\n\nDevers Drop Device (D3) app: A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Baseline Adherence', 'description': 'All subjects pre-randomization had the device with no reminders. If they took their eye drops at least 90% of the prescribed number of days they left the study', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 1, 'seriousNumAtRisk': 50, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vertigo', 'notes': 'Happened sometime during the month long period. Went away before returning to clinic. Believed to be non-serious and unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'vertigo'}, {'term': 'Adenoviral Conjunctivitis', 'notes': 'Subject developed conjunctivitis unrelated to the study treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Compliance Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control - no Reminder', 'description': 'For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation.'}, {'id': 'OG001', 'title': 'Integrated Daily Reminder Using the D3 App', 'description': 'For Group 2, they will have their D3 app turned on to deliver both a push notification reminder to their smart phone and audio and visual reminders to their D3 device.\n\nDevers Drop Device (D3) app: A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.'}, {'id': 'OG002', 'title': 'Baseline Adherence', 'description': 'All subjects received the device with no reminders and were monitored on how often they took their drops. If the drops were taken less than 90% of the required days, they were randomized to group 1 or 2'}], 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'spread': 'NA', 'comment': 'Mean and Standard Deviation not available since only 1 participant was analyzed for the assessment', 'groupId': 'OG000'}, {'value': '94.6', 'spread': '7.6', 'groupId': 'OG001'}, {'value': '93.99', 'spread': '16.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '50 days', 'description': 'Compliance percentage by dividing the number of days the dose monitor recorded dosing within 3 hours of the prescribed time by the number of days in the study cycle', 'unitOfMeasure': 'percentage of days dose monitor recorded', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control - no Reminder', 'description': 'For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation.'}, {'id': 'OG001', 'title': 'Integrated Daily Reminder Using the D3 App', 'description': 'For Group 2, they will have their D3 app turned on to deliver both a push notification reminder to their smart phone and audio and visual reminders to their D3 device.\n\nDevers Drop Device (D3) app: A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.'}, {'id': 'OG002', 'title': 'Baseline Adherence', 'description': 'Anyone who was not randomized into group 1 or 2 after taking their drops at least 90% of the time'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'spread': 'NA', 'comment': 'Standard Deviation not available since only 1 participant was analyzed for the assessment', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '22.1', 'spread': '3.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '50 days', 'description': "The investigators will also measure the participants' satisfaction with the dose monitor using a short Likert questionnaire. The questionnaire will include 5 questions. Each question will offer choices 1-5 with an overall minimum summed score of 5 and a maximum summed score of 25. Higher score will indicate higher satisfaction.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control - no Reminder', 'description': 'For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation.'}, {'id': 'FG001', 'title': 'Integrated Daily Reminder Using the D3 App', 'description': 'For Group 2, they will have their D3 app turned on to deliver both a push notification reminder to their smart phone and audio and visual reminders to their D3 device.\n\nDevers Drop Device (D3) app: A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.'}, {'id': 'FG002', 'title': 'Baseline Adherence Test', 'description': "During the initial testing to determine baseline adherence to the subject's glaucoma medication. If the subject's did not take their medication at least 90% of the time, they qualified to be randomized into the other 2 groups/arms"}], 'periods': [{'title': 'Stage 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '45'}]}]}, {'title': 'Stage 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control - no Reminder', 'description': 'For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation.'}, {'id': 'BG001', 'title': 'Integrated Daily Reminder Using the D3 App', 'description': 'For Group 2, they will have their D3 app turned on to deliver both a push notification reminder to their smart phone and audio and visual reminders to their D3 device.\n\nDevers Drop Device (D3) app: A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.'}, {'id': 'BG002', 'title': 'Baseline Adherence', 'description': 'Before randomizing subjects, all were given the device to observe if their adherence to their own medication was worse than 90% of the time. If so, they would enter the second stage and be placed in Group 1 or 2'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'spread': '6.36', 'groupId': 'BG000'}, {'value': '64', 'spread': '8.88', 'groupId': 'BG001'}, {'value': '68.13', 'spread': '11.17', 'groupId': 'BG002'}, {'value': '67.8', 'spread': '8.75', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Caucasian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Hispanic', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian or Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-02', 'size': 363808, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_004.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-07T13:26', 'hasProtocol': True}, {'date': '2020-02-11', 'size': 212791, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-11-07T18:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2018-04-14', 'resultsFirstSubmitDate': '2022-10-03', 'studyFirstSubmitQcDate': '2018-04-23', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-17', 'studyFirstPostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance Percentage', 'timeFrame': '50 days', 'description': 'Compliance percentage by dividing the number of days the dose monitor recorded dosing within 3 hours of the prescribed time by the number of days in the study cycle'}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': '50 days', 'description': "The investigators will also measure the participants' satisfaction with the dose monitor using a short Likert questionnaire. The questionnaire will include 5 questions. Each question will offer choices 1-5 with an overall minimum summed score of 5 and a maximum summed score of 25. Higher score will indicate higher satisfaction."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Adherence', 'Medication', 'Glaucoma', 'Device'], 'conditions': ['Medication Adherence', 'Glaucoma']}, 'descriptionModule': {'briefSummary': 'Glaucoma is the second leading cause of visual impairment worldwide. Eye drop medications reduce vision loss from glaucoma by at least 60%, but eye drops must be taken every day to be effective. However, adherence to eye drop treatment is poor with only 50% of patients regularly taking their prescribed eye drops. The investigators are developing the Devers Drop Device (D3) eye drop monitor to accurately measure eye drop cap removal and to improve eye drop-taking behavior. The investigators will test eye drop adherence with the D3 device in a randomized, prospective clinical trial.', 'detailedDescription': 'Universal Adherence is an emerging medical device company dedicated to improving adherence to ocular medications through innovative technical solutions. The Devers Drop Device (D3) will accurately track when a patient removes an eye drop bottle cap, communicate usage data wirelessly to a database that researchers can access, and send alerts to patients when a medication is due. In addition to helping patients maintain their dosing schedule, the D3 will also provide adherence information to researchers and eye care providers, which will help to understand poor treatment outcomes and to develop improved treatment strategies.The clinical benefits of the device in improving adherence will initially be assessed and targeted towards glaucoma, but the ability of the device to be attached to all FDA-approved eye drop bottle caps will make this device attractive to all patients that need consistent daily use of eye drops.\n\nRandomized, prospective clinical trial: The investigators will enroll 50 participants (25 male, 25 female) into a prospective trial with duration of up to 50 days. The inclusion criteria are those who are prescribed latanoprost eye drop to be used once per day at bedtime, and own a functioning Android or Apple iphone smartphone (iOs) with Bluetooth and cellular connectivity. The investigators will exclude patients who currently use smartphone medication reminders and those with severe cognitive impairment limiting their ability to understand a questionnaire. The 50-day period is useful for glaucoma studies because patients revert to their normal dosing pattern within two weeks after their last visit. This study will include two stages: Stage 1) a 25-day period evaluating baseline patient adherence with the D3 device; and Stage 2) a subsequent 25-day period to determine the effect of no reminder versus daily reminder using the D3 app, which includes integrated audio and visual reminders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are prescribed latanoprost eye drop to be used once per day at bedtime, and own a functioning smartphone and have a password-protected home wireless connection.\n\nExclusion Criteria:\n\n* Patients who currently use smartphone medication reminders and those with severe cognitive impairment limiting their ability to understand a questionnaire.'}, 'identificationModule': {'nctId': 'NCT03506568', 'briefTitle': 'A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications', 'organization': {'class': 'INDUSTRY', 'fullName': 'Universal Adherence LLC'}, 'officialTitle': 'A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications', 'orgStudyIdInfo': {'id': 'UniversalAdherence'}, 'secondaryIdInfos': [{'id': '1R41EY028807-01', 'link': 'https://reporter.nih.gov/quickSearch/1R41EY028807-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control - no reminder', 'description': 'For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation.'}, {'type': 'EXPERIMENTAL', 'label': 'Integrated daily reminder using the D3 app', 'description': 'For Group 2, they will have their D3 app turned on to deliver both a push notification reminder to their smart phone and audio and visual reminders to their D3 device.', 'interventionNames': ['Device: Devers Drop Device (D3) app']}], 'interventions': [{'name': 'Devers Drop Device (D3) app', 'type': 'DEVICE', 'description': 'A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.', 'armGroupLabels': ['Integrated daily reminder using the D3 app']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Robert Kinast', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Steve L Mansberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universal Adherence LLC'}, {'name': 'David Porter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will only be shared internally with co-investigators and those performing analysis of data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universal Adherence LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Oregon State University', 'class': 'OTHER'}, {'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}