Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT01281020
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2011-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adherence With Fixed Versus Unfixed Glaucoma Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D017889', 'term': 'Exfoliation Syndrome'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2011-01-20', 'studyFirstSubmitQcDate': '2011-01-20', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of adherence', 'timeFrame': '6 months', 'description': 'Rate of asherence with fixed vs unfixed glaucoma therapy'}], 'secondaryOutcomes': [{'measure': 'Ocular surface evaluation', 'timeFrame': '6 months', 'description': 'Objective and subjective signs of ocular surface health'}, {'measure': 'Treatment satisfaction', 'timeFrame': '6 months', 'description': 'To document satisfaction with therapy this study will employ questions selected from a validated treatment satisfaction questionnaire (questions 10-15, Treatment Satisfaction Survey-Intraocular Pressure) as published by Day et al (Eye 2006; 20: 583-590). The survey will assess the level of satisfaction and overall quality-of-life with latanoprost/timolol fixed combination versus unfixed therapy in this study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Adherence', 'Fixed combination therapy'], 'conditions': ['Primary Open-angle Glaucoma', 'Ocular Hypertension', 'Exfoliation Glaucoma']}, 'descriptionModule': {'briefSummary': 'A 6-month, parallel, non-interventional trial investigating the level of adherence and the impact of dosing in open-angle glaucoma patients who receive either unfixed therapy with latanoprost once in the evening and timolol twice daily, or latanoprost/timolol fixed combination therapy once in the evening. All patients participating in this observational study will be monitored for their adherence with the use of Medication Event Monitoring System (MEMS). At the end of treatment periods treatment satisfaction will be assessed with selected questions from the Treatment Satisfaction Survey-Intraocular Pressure survey. This study will monitor objectively, for the first time, adherence and intraocular pressure control with fixed versus unfixed therapy. Finally it will help us to elucidate the impact of dosing (once-a-day versus three-times-daily) on the level of adherence in glaucoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who use latanoprost/timolol fixed combination therapy with once-a-day dosing in the evening\n\nAll patients already treated with timolol twice daily and latanoprost once in the evening', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is between 21-80 years old\n* Patient has ocular hypertension or open-angle glaucoma Patient receives therapy and is well controlled on fixed or unfixed latanoprost and timolol therapy\n* Untreated IOP \\>19 mm Hg \\<33 mm Hg at baseline (10:00 hour)\n* Open normal appearing angles\n* Patient had at least a 20% reduction vs untreated baseline on current therapy\n* Patient has early or moderate glaucoma (\\< 14 decibel; 0.8 or better cupping)\n* Distance best corrected Snellen visual acuity greater than 1/10\n\nExclusion Criteria:\n\n* Contraindication to timolol or prostaglandin therapy\n* History of lack of response to any medication (\\< 10%)\n* Patient does not understand the instructions and will not comply to medications\n* Patient can not attend follow up\n* Patient is a female of childbearing potential, or lactating mother\n* History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses\n* Sign of ocular infection\n* A corneal abnormality that may affect IOP measurements'}, 'identificationModule': {'nctId': 'NCT01281020', 'briefTitle': 'Adherence With Fixed Versus Unfixed Glaucoma Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'A 3-month, Observational Study Investigating With Electronic Monitoring the Level of Adherence and Treatment Satisfaction With Latanoprost/Timolol Fixed Combination Versus Unfixed Therapy in Open-angle Glaucoma', 'orgStudyIdInfo': {'id': 'NIS50/01/08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment with fixed combination', 'description': 'Patients who receive treatment with latanoprost/timolol fixed combination'}, {'label': 'Treatment with unfixed therapy', 'description': 'Patients who receive latanoprost and timolol therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '546 36', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Glaucoma Unit, 1st University Department of Ophthalmology, AHEPA Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Anastasios G Konstas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glaucoma Unit, 1st University Department of Ophthalmology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Ophthalmology', 'investigatorFullName': 'AGP Konstas', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}