Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT00603005
Status:
COMPLETED
Last Update Posted:
2010-02-24
First Post:
2008-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adherence Improvement in Glaucoma Patients
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 802}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-23', 'studyFirstSubmitDate': '2008-01-15', 'studyFirstSubmitQcDate': '2008-01-26', 'lastUpdatePostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Information with regard to the use of eye drops from data generated by the TravAlert dosing system', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glaucoma', 'Adherence'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the effect on intraocular pressure in glaucoma patients using the TravAlert dosing aid with or without the Eyot drop guider and with or without additional patient education.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis glaucoma or ocular hypertension\n* Treatment with travoprost or travoprost/timolol\n\nExclusion Criteria:\n\n* High risk of side effects expected from travoprost or travoprost/timolol\n* Absolute inability to administer eye drops\n* Difficulty in reading or speaking Dutch'}, 'identificationModule': {'nctId': 'NCT00603005', 'briefTitle': 'Adherence Improvement in Glaucoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Adherence Improvement in Glaucoma Patients', 'orgStudyIdInfo': {'id': 'MEC 07-1-015'}, 'secondaryIdInfos': [{'id': 'CTCM-071015'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Device: Use of TravAlert dosing aid with or without drop guider']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Device: Use of TravAlert dosing aid with or without drop guider']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Device: Use of TravAlert dosing aid with or without drop guider']}, {'type': 'EXPERIMENTAL', 'label': '4', 'interventionNames': ['Device: Use of TravAlert dosing aid with or without drop guider']}], 'interventions': [{'name': 'Use of TravAlert dosing aid with or without drop guider', 'type': 'DEVICE', 'description': 'Each patient will use a dosing aid and/or drop guider for 6 months', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'city': "'s-Hertogenbosch", 'country': 'Netherlands', 'facility': 'Jeroen Bosch ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Medisch centrum Alkmaar', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'city': 'Assen', 'country': 'Netherlands', 'facility': 'Wilhelmina ziekenhuis', 'geoPoint': {'lat': 52.99667, 'lon': 6.5625}}, {'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Deventer', 'country': 'Netherlands', 'facility': 'Deventer ziekenhuis', 'geoPoint': {'lat': 52.255, 'lon': 6.16389}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Gouda', 'country': 'Netherlands', 'facility': 'Groene hart ziekenhuis', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'city': 'Heerenveen', 'country': 'Netherlands', 'facility': 'ziekenhuis de Tjongerschans', 'geoPoint': {'lat': 52.95929, 'lon': 5.91854}}, {'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Atrium medisch centrum', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'city': 'Hoorn', 'country': 'Netherlands', 'facility': 'Westfries gasthuis', 'geoPoint': {'lat': 52.6425, 'lon': 5.05972}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'University hospital', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Canisius Wilhelmina ziekenhuis', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus medisch centrum', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala klinieken', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Helena J Beckers, MD/phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. H.J.M. Beckers, MD, phD', 'oldOrganization': 'Department of Ophthalmology, University Hospital Maastricht'}}}}