Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-01-03 @ 8:21 PM
Study NCT ID:
NCT00293761
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2006-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069557', 'term': 'Travoprost'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-17', 'studyFirstSubmitDate': '2006-02-17', 'studyFirstSubmitQcDate': '2006-02-17', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean IOP'}]}, 'conditionsModule': {'keywords': ['open-angle', 'glaucoma', 'ocular', 'hypertension'], 'conditions': ['Open-angle Glaucoma', 'Ocular Hypertension']}, 'referencesModule': {'references': [{'pmid': '18414108', 'type': 'RESULT', 'citation': 'Gross RL, Peace JH, Smith SE, Walters TR, Dubiner HB, Weiss MJ, Ochsner KI. Duration of IOP reduction with travoprost BAK-free solution. J Glaucoma. 2008 Apr-May;17(3):217-22. doi: 10.1097/IJG.0b013e31815a3472.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether a glaucoma therapy is safe and effective in treating 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 of either sex of any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Under age 18.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00293761', 'briefTitle': 'A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'C-05-51'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Travatan, Investigational', 'interventionNames': ['Drug: Travoprost, Investigational']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Travatan', 'interventionNames': ['Drug: Travoprost (TRAVATAN)']}], 'interventions': [{'name': 'Travoprost, Investigational', 'type': 'DRUG', 'description': 'One drop in study eye once daily for 13 days', 'armGroupLabels': ['Travatan, Investigational']}, {'name': 'Travoprost (TRAVATAN)', 'type': 'DRUG', 'otherNames': ['TRAVATAN'], 'description': 'One drop in study eye once daily for 13 days', 'armGroupLabels': ['Travatan']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}