Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-13 @ 12:11 PM
Study NCT ID:
NCT00620256
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2008-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Study of AL-37807 Ophthalmic Suspension
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': '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': 'D000077338', 'term': 'Latanoprost'}], 'ancestors': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'dispFirstSubmitDate': '2012-12-03', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-03', 'studyFirstSubmitDate': '2008-02-11', 'dispFirstSubmitQcDate': '2012-12-03', 'studyFirstSubmitQcDate': '2008-02-11', 'dispFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from baseline in intraocular pressure', 'timeFrame': 'Baseline, up to 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Hypertension'], 'conditions': ['Open-Angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all dosed concomitantly with Xalatan, 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* Open-angle glaucoma\n* Ocular hypertension\n* Must have been on Xalatan for at least 3 months\n* VA not worse than 0.60\n* Other protocol-defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Age related\n* Other protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00620256', 'briefTitle': 'Adjunctive Study of AL-37807 Ophthalmic Suspension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Comparison of Safety and Efficacy of Al-37807 Ophthalmic Suspension vs. Timolol Gel Forming Solution and Vehicle, All Dosed Concomitantly With Xalatan in Patients With Open-Angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': 'C-07-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AL-37807', 'description': 'AL-37807 ophthalmic suspension, 0.1%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks', 'interventionNames': ['Drug: AL-37807 ophthalmic suspension, 0.1%', 'Drug: Latanoprost ophthalmic solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol', 'description': 'Timolol gel forming solution, 0.5%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks', 'interventionNames': ['Drug: Timolol gel forming solution, 0.5%', 'Drug: Latanoprost ophthalmic solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'AL-37807 vehicle', 'description': 'AL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks', 'interventionNames': ['Drug: AL-37807 ophthalmic suspension, 0.1%', 'Other: AL-37807 ophthalmic solution vehicle', 'Drug: Latanoprost ophthalmic solution']}], 'interventions': [{'name': 'AL-37807 ophthalmic suspension, 0.1%', 'type': 'DRUG', 'armGroupLabels': ['AL-37807', 'AL-37807 vehicle']}, {'name': 'Timolol gel forming solution, 0.5%', 'type': 'DRUG', 'armGroupLabels': ['Timolol']}, {'name': 'AL-37807 ophthalmic solution vehicle', 'type': 'OTHER', 'armGroupLabels': ['AL-37807 vehicle']}, {'name': 'Latanoprost ophthalmic solution', 'type': 'DRUG', 'otherNames': ['XALATAN'], 'armGroupLabels': ['AL-37807', 'AL-37807 vehicle', 'Timolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center at 1-888-451-3937', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}