Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-01-06 @ 8:13 PM
Study NCT ID:
NCT03858894
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2019-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6
Sponsor:
Organization:
Raw JSON
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At Santen's request Site/Investigator has to withhold any publication if there is a patentable invention until such time as Santen is able to secure adequate patent protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.', 'eventGroups': [{'id': 'EG000', 'title': 'Test Arm: DE-117 BID', 'description': 'DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)\n\nDE-117 Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 20, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Drug Arm: DE-117 QD', 'description': 'DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD\n\nDE-117 Ophthalmic Solution QD: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 7, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Accommodation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Corneal pigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Glare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ocular discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vital dye staining cornea present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP) at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Arm: DE-117 BID', 'description': 'DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)\n\nDE-117 Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye'}, {'id': 'OG001', 'title': 'Drug Arm: DE-117 QD', 'description': 'DE-117 Ophthalmic Solution QD (20:00) and 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Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye'}, {'id': 'OG001', 'title': 'Drug Arm: DE-117 QD', 'description': 'DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD\n\nDE-117 Ophthalmic Solution QD: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye'}], 'classes': [{'categories': [{'measurements': [{'value': '17.73', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '18.17', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12:00 at week 2', 'description': 'Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP) at Week 2', 'denoms': [{'units': 'Participants', 'counts': 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'timeFrame': '08:00 at week 6', 'description': 'Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Arm: DE-117 BID', 'description': 'DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)\n\nDE-117 Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye'}, {'id': 'OG001', 'title': 'Drug Arm: DE-117 QD', 'description': 'DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD\n\nDE-117 Ophthalmic Solution QD: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye'}], 'classes': [{'categories': [{'measurements': [{'value': '17.77', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '18.35', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12:00 at week 6', 'description': 'Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Arm: DE-117 BID', 'description': 'DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)\n\nDE-117 Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye'}, {'id': 'OG001', 'title': 'Drug Arm: DE-117 QD', 'description': 'DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD\n\nDE-117 Ophthalmic Solution QD: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye'}], 'classes': [{'categories': [{'measurements': [{'value': '17.30', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '17.66', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '16:00 at week 6', 'description': 'Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Diurnal Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Arm: DE-117 BID', 'description': 'DE-117 Ophthalmic Solution BID Twice daily (20:00 and 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'48', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Test Arm: DE-117 BID', 'description': 'DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)\n\nDE-117 Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye'}, {'id': 'BG001', 'title': 'Drug Arm: DE-117 QD', 'description': 'DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD\n\nDE-117 Ophthalmic Solution QD: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.3', 'spread': '9.45', 'groupId': 'BG000'}, {'value': '66.3', 'spread': '8.73', 'groupId': 'BG001'}, {'value': '66.8', 'spread': '9.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-13', 'size': 925817, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-03T12:43', 'hasProtocol': True}, {'date': '2019-07-11', 'size': 906127, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-03T12:44', 'hasProtocol': False}]}}, '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': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2019-02-27', 'resultsFirstSubmitDate': '2020-07-20', 'studyFirstSubmitQcDate': '2019-02-27', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-20', 'studyFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure (IOP) at Week 2', 'timeFrame': '08:00 at week 2', 'description': 'Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).'}, {'measure': 'Intraocular Pressure (IOP) at Week 2', 'timeFrame': '12:00 at week 2', 'description': 'Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).'}, {'measure': 'Intraocular Pressure (IOP) at Week 2', 'timeFrame': '16:00 at week 2', 'description': 'Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...'}, {'measure': 'Intraocular Pressure (IOP) at Week 6', 'timeFrame': '08:00 at week 6', 'description': 'Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).'}, {'measure': 'Intraocular Pressure (IOP) at Week 6', 'timeFrame': '12:00 at week 6', 'description': 'Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).'}, {'measure': 'Intraocular Pressure (IOP) at Week 6', 'timeFrame': '16:00 at week 6', 'description': 'Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...'}], 'secondaryOutcomes': [{'measure': 'Mean Diurnal Intraocular Pressure (IOP)', 'timeFrame': '6 weeks', 'description': 'Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Open-angle Glaucoma and Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their current topical IOP lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up to 6 weeks.\n\nApproximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:\n\n* DE-117 ophthalmic solution 0.002% QD (Once Daily)\n* DE-117 ophthalmic solution 0.002% BID (Twice Daily)\n\nThis study will consist of a screening period of up to 35 days including a washout period of up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nProvide signed written informed consent\n\n* Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.\n* Qualifying corrected visual acuity in each eye\n* Qualifying central corneal thickness in each eye\n* Qualifying Day 1 IOP measurement at 3 time-points in both eyes\n* Qualifying Anterior chamber angle\n\nExclusion Criteria:\n\n* History of ocular surgery specifically intended to lower IOP\n* Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period\n* Advanced glaucoma in either eye\n* Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry\n* Any ocular surgery or ocular laser treatment within 180 days prior to Screening and throughout the study in either eye\n* Females who are pregnant, nursing, or planning a pregnancy'}, 'identificationModule': {'nctId': 'NCT03858894', 'briefTitle': 'Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen Inc.'}, 'officialTitle': 'A Randomized, Double-Masked, Parallel-Group, Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension SPECTRUM 6 Study.', 'orgStudyIdInfo': {'id': '011712IN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug Arm: DE-117 QD', 'description': 'DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD', 'interventionNames': ['Drug: DE-117 Ophthalmic Solution QD']}, {'type': 'EXPERIMENTAL', 'label': 'Test Arm: DE-117 BID', 'description': 'DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)', 'interventionNames': ['Drug: DE-117 Ophthalmic Solution BID']}], 'interventions': [{'name': 'DE-117 Ophthalmic Solution QD', 'type': 'DRUG', 'description': 'DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye', 'armGroupLabels': ['Drug Arm: DE-117 QD']}, {'name': 'DE-117 Ophthalmic Solution BID', 'type': 'DRUG', 'description': 'DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye', 'armGroupLabels': ['Test Arm: DE-117 BID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90013', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'East West Eye Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Danbury Eye Specialist', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '34613', 'city': 'Brooksville', 'state': 'Florida', 'country': 'United States', 'facility': 'Hernando Eye Institute', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Levenson Eye Associates', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '21078', 'city': 'Havre de Grace', 'state': 'Maryland', 'country': 'United States', 'facility': 'Seidenberg Protzko Eye Associates', 'geoPoint': {'lat': 39.54928, 'lon': -76.09162}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Tekwani Vision Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08361', 'city': 'Vineland', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Eye Associates/SurgiCenter of Vineland', 'geoPoint': {'lat': 39.48623, 'lon': -75.02573}}, {'zip': '11563', 'city': 'Lynbrook', 'state': 'New York', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Long Island', 'geoPoint': {'lat': 40.65483, 'lon': -73.6718}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Apex Eye Clinical Research, LLC', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44115', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Abrams Eye Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scott & Christie and Associates PC', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '37803', 'city': 'Maryville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University Eye Specialist', 'geoPoint': {'lat': 35.75647, 'lon': -83.97046}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Advanced Vision Research', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}