Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-28 @ 2:20 AM
Study NCT ID:
NCT00465803
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
2007-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase IIIb Study of DuoTrav to Treat Glaucoma or Ocular Hypertension
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'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069557', 'term': 'Travoprost'}, {'id': 'D013999', 'term': 'Timolol'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'id': 'C571754', 'term': 'Duotrav'}], 'ancestors': [{'id': 'D003008', 'term': 'Cloprostenol'}, {'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'dispFirstSubmitDate': '2014-07-22', 'lastUpdateSubmitDate': '2014-07-22', 'studyFirstSubmitDate': '2007-04-23', 'dispFirstSubmitQcDate': '2014-07-22', 'studyFirstSubmitQcDate': '2007-04-24', 'dispFirstPostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient compliance', 'timeFrame': '12 months', 'description': 'Patient compliance will be measured with a dosing aid that records time and date of study drug administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Open-angle glaucoma or ocular hypertension'], 'conditions': ['Open-angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess patient compliance with DuoTrav versus concomitant administration of Timolol 0.5% plus TRAVATAN in patients with open-angle glaucoma or ocular hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with open-angle glaucoma or ocular hypertension;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Visual acuity worse than 0.60;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00465803', 'briefTitle': 'A Phase IIIb Study of DuoTrav to Treat Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Compliance Study Comparing DuoTrav to TRAVATAN Plus Timolol Using the Dosing Aid', 'orgStudyIdInfo': {'id': 'C-06-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DuoTrav', 'description': 'One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months, as recorded by dosing aid', 'interventionNames': ['Drug: Travoprost 0.004%/timolol 0.5% ophthalmic solution']}, {'type': 'OTHER', 'label': 'Travatan/Timolol', 'description': 'One drop Timolol in the study eye(s) once daily at 8 AM; one drop of Travatan in the study eye(s) once daily at 8 PM. Both products dosed for twelve months, as recorded by separate dosing aid for each product.', 'interventionNames': ['Drug: Travoprost ophthalmic solution, 0.004%', 'Drug: Timolol maleate ophthalmic solution, 0.5%']}], 'interventions': [{'name': 'Travoprost 0.004%/timolol 0.5% ophthalmic solution', 'type': 'DRUG', 'otherNames': ['DuoTrav'], 'description': 'One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months using the Dosing Aid', 'armGroupLabels': ['DuoTrav']}, {'name': 'Travoprost ophthalmic solution, 0.004%', 'type': 'DRUG', 'otherNames': ['TRAVATAN'], 'description': 'One drop in the study eye(s) once daily at 8 PM for twelve months using the Dosing Aid', 'armGroupLabels': ['Travatan/Timolol']}, {'name': 'Timolol maleate ophthalmic solution, 0.5%', 'type': 'DRUG', 'description': 'One drop in the study eye(s) once daily at 8 AM or twelve months using the Dosing Aid', 'armGroupLabels': ['Travatan/Timolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Theresa Landry', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}