Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-26 @ 1:28 PM
Study NCT ID:
NCT01055366
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
2010-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ELAZOP Switching Study in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571752', 'term': 'Azarga'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-13', 'studyFirstSubmitDate': '2010-01-22', 'studyFirstSubmitQcDate': '2010-01-22', 'lastUpdatePostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Intraocular Pressure (IOP) change from baseline at final visit.', 'timeFrame': '12 weeks after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Open angle glaucoma', 'OAG', 'Elazop', 'Azarga', 'Brinzolamide/Timolol combination'], 'conditions': ['Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of switching to ELAZOP from prior pharmacotherapy in patients with open-angled glaucoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older.\n* Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.\n* Must be on a stable regimen of Intraocular Pressure (IOP) lowering medication (i.e., either a single therapeutic agent or two separate ocular hypotensive agents) for at least one month prior to the Screening Visit.\n* Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.\n* Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in the study that is deemed clinically significant in the opinion of the Principal Investigator.\n* Intraocular conventional surgery or laser surgery in either eye less than three months prior to the Screening visit.\n* History of ocular herpes simplex.\n* Pregnant or lactating.\n* Participation in any other investigational study within 30 days of Screening visit.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01055366', 'briefTitle': 'ELAZOP Switching Study in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'RM-09-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elazop (Azarga)', 'description': 'Elazop Treatment arm', 'interventionNames': ['Drug: Elazop (Azarga)']}], 'interventions': [{'name': 'Elazop (Azarga)', 'type': 'DRUG', 'description': 'Administer one drop of ELAZOP in treated eye(s) twice a day for up to 12 weeks', 'armGroupLabels': ['Elazop (Azarga)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '705-707', 'city': 'Daegu', 'state': 'Daegu', 'country': 'South Korea', 'facility': 'Youngnam Univ. Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '463-707', 'city': 'Sungnam', 'state': 'Gyounggi', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital'}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-720', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Kangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-040', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Mary's Hospital, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-706', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '150-034', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Kim's Eye Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '150-703', 'city': 'Seoul', 'country': 'South Korea', 'facility': "St. Mary's Hospital, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}