Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-30 @ 12:36 PM
Study NCT ID:
NCT00626067
Status:
COMPLETED
Last Update Posted:
2016-11-10
First Post:
2008-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Patient Use and Perception of the Travatan Dosing Aid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-08', 'studyFirstSubmitDate': '2008-01-22', 'studyFirstSubmitQcDate': '2008-02-19', 'lastUpdatePostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser", 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Pilot study of the impact of physician monitoring of compliance on patient compliance', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Travatan Dosing Aid', 'compliance monitoring dispenser'], 'conditions': ['Glaucoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.2147/PPA.S114746', 'label': 'Patient Preference and Adherence'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the opinions of patients who are given the Travatan Compliance Monitoring Dispenser to use to dispense their Travatan glaucoma drops.', 'detailedDescription': "Patients enrolled in this study will use the new Travatan compliance monitoring dispenser for 6 weeks. Patients will be informed that some, but not all, patients' compliance will be monitored by the device. Patients are randomly assigned to one of three groups (proportionally in a 2/2/1 ratio):\n\n1. Fully functional Travatan compliance monitor\n2. Travatan compliance monitor with LCD display and alarms disabled, but compliance monitoring intact\n3. Travatan compliance monitor with LCD display, alarms and compliance monitor disabled.\n\nAt end of study, patients fill out questionnaire assessing\n\n1. Patient opinion regarding device: ease of use of new device; preference vs Travatan use without device, etc\n2. patient's belief as to whether their compliance was monitored or not\n\nRates of adherence are compared across groups and with regard to patients' reported beliefs as to whether they were monitored.\n\nThe design of this study should allow the clinicians to ethically monitor compliance in patients who do and do not believe that they are being monitored. The use of monitoring devices without a functioning display and alarm should lead to some patients believing that they are not being monitored. As patients are told at the outset that they may or may not be monitored, this should be an ethically acceptable design. However, the collected data will allow a preliminary assessment of the impact of the patients' beliefs as to whether they are being monitored on their actual compliance, and hence an additional potential value of the device."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Open angle glaucoma or ocular hypertension\n* Presently using Travatan eye drops\n\nExclusion Criteria:\n\n* Allergy to prostaglandin'}, 'identificationModule': {'nctId': 'NCT00626067', 'briefTitle': 'Study of Patient Use and Perception of the Travatan Dosing Aid', 'organization': {'class': 'OTHER', 'fullName': 'Wills Eye'}, 'officialTitle': 'Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid)', 'orgStudyIdInfo': {'id': 'IRB #06-762E'}, 'secondaryIdInfos': [{'id': 'CMS-06-09', 'type': 'OTHER', 'domain': 'Wills Eye Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 Fully functional monitoring device', 'description': 'Fully functional monitoring device', 'interventionNames': ['Device: Fully functional monitoring device']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Partially functional monitoring device', 'description': 'Partially functional monitoring device', 'interventionNames': ['Device: Partially functional monitoring device']}, {'type': 'SHAM_COMPARATOR', 'label': '3 Non-functional monitoring device', 'description': 'Non-functional monitoring device', 'interventionNames': ['Device: Non-functional monitoring device']}], 'interventions': [{'name': 'Fully functional monitoring device', 'type': 'DEVICE', 'description': 'Pt received fully functional monitoring dispenser for use with their Travatan eye drops', 'armGroupLabels': ['1 Fully functional monitoring device']}, {'name': 'Partially functional monitoring device', 'type': 'DEVICE', 'description': 'Patient received a particually functional Travatan Compliance Monitoring Dispenser', 'armGroupLabels': ['2 Partially functional monitoring device']}, {'name': 'Non-functional monitoring device', 'type': 'DEVICE', 'description': 'Patient received a non functioning Travatan Compliance Monitoring Dispenser', 'armGroupLabels': ['3 Non-functional monitoring device']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jonathan S. Myers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wills Eye Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'A Manuscript has been accepted and published in Patient Preference and Adherence.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wills Eye', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Surgeon', 'investigatorFullName': 'Jonathon Myers', 'investigatorAffiliation': 'Wills Eye'}}}}