Ignite Creation Date:
2025-12-25 @ 1:59 AM
Ignite Modification Date:
2026-02-20 @ 6:45 AM
Study NCT ID:
NCT00868894
Status:
COMPLETED
Last Update Posted:
2011-11-03
First Post:
2009-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-05-25', 'releaseDate': '2017-04-17'}], 'estimatedResultsFirstSubmitDate': '2017-04-17'}}, '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': '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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-01', 'studyFirstSubmitDate': '2009-03-23', 'studyFirstSubmitQcDate': '2009-03-23', 'lastUpdatePostDateStruct': {'date': '2011-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the safety and efficacy of two concentrations of DE-104 ophthalmic solution with placebo and 0.005% latanoprost in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.', 'timeFrame': '15 days'}], 'secondaryOutcomes': [{'measure': 'To investigate the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.', 'timeFrame': '15 days'}]}, 'conditionsModule': {'conditions': ['Open-Angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'To investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provided signed, written informed consent.\n* 18 years of age and older.\n* Diagnosed with primary open-angle glaucoma or ocular hypertension.\n* If a subject is a female of childbearing potential she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.\n\nExclusion Criteria:\n\n* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.\n* Presence of any abnormality or significant illness that could be expected to interfere with the study.'}, 'identificationModule': {'nctId': 'NCT00868894', 'briefTitle': 'Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen Inc.'}, 'officialTitle': 'A Randomized, Double-masked, Placebo- and Active-controlled, Multi-Center, Dose Escalation Trial of DE-104 Ophthalmic Solution in Japanese and Non-Japanese Subjects With Primary Open-angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': '27-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: DE-104 medium concentration']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: DE-104 high concentration']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: 0.005% latanoprost']}], 'interventions': [{'name': 'DE-104 medium concentration', 'type': 'DRUG', 'description': 'Topical ocular application', 'armGroupLabels': ['1']}, {'name': 'DE-104 high concentration', 'type': 'DRUG', 'description': 'Topical ocular application', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Topical ocular application', 'armGroupLabels': ['3']}, {'name': '0.005% latanoprost', 'type': 'DRUG', 'description': 'Topical ocular application', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90701', 'city': 'Artesia', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.86585, 'lon': -118.08312}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96734', 'city': 'Kailua', 'state': 'Hawaii', 'country': 'United States', 'geoPoint': {'lat': 21.40241, 'lon': -157.74054}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-04-17', 'type': 'RELEASE'}, {'date': '2017-05-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Santen Inc.'}}}}