Ignite Creation Date:
2025-12-17 @ 1:46 PM
Ignite Modification Date:
2025-12-23 @ 4:53 PM
Study NCT ID:
NCT05495061
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2022-08-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-03', 'studyFirstSubmitDate': '2022-08-09', 'studyFirstSubmitQcDate': '2022-08-09', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in mean diurnal intraocular pressure', 'timeFrame': '4 weeks', 'description': 'Change from baseline in mean diurnal intraocular pressure at Week 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Open Angle Glaucoma, Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'To investigate whether the IOP lowering efficacy of STN1012600 ophthalmic solution 0.002% is non-inferior to that of latanoprost 0.005% in subjects with POAG or OHT after treatment for 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older.\n* Diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.\n* Corrected Visual Acuity of +0.60 logMAR (Decimal visual acuity 0.3) or better in each eye.\n\nExclusion Criteria:\n\n* Presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids in either eye.\n* History of severe ocular trauma in either eye.\n* Any condition that prevents clear visualization of the fundus in either eye.\n* Known allergy, hypersensitivity or contraindications to any components of the study medications or other study related procedures/medications.\n* History of ocular surgery specifically intended to lower IOP in either eye.\n* History of keratorefractive surgery in either eye.\n* Females who are pregnant, nursing, or planning a pregnancy.\n* Subjects with known or suspected drug or alcohol abuse.\n* Participation in other investigational drugs or device clinical trials within 30 days prior to Screening.\n* Any decision by the Investigator to terminate a subject in screening or declare any subject ineligible for any sound medical reason.'}, 'identificationModule': {'nctId': 'NCT05495061', 'briefTitle': 'A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1012600 Ophthalmic Solution 0.002% Compared With Latanoprost 0.005% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (Angel-J1 Study)', 'orgStudyIdInfo': {'id': '101260005LT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STN1012600 0.002%', 'interventionNames': ['Drug: STN1012600 ophthalmic solution 0.002%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Latanoprost 0.005%', 'interventionNames': ['Drug: Latanoprost ophthalmic solution 0.005%']}], 'interventions': [{'name': 'STN1012600 ophthalmic solution 0.002%', 'type': 'DRUG', 'description': '1 drop STN1012600 ophthalmic solution 0.002% once daily for 3 months', 'armGroupLabels': ['STN1012600 0.002%']}, {'name': 'Latanoprost ophthalmic solution 0.005%', 'type': 'DRUG', 'description': '1 drop Latanoprost ophthalmic solution 0.005% once daily for 3 months', 'armGroupLabels': ['Latanoprost 0.005%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'country': 'Japan', 'facility': 'Eyecare Nagoya', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Kitanagoya Eye Clinic', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Takahashi Eye Clinic', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Kawabata Eye Clinic', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Mitsuhashi Eye Clinic', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Shisui Ophthalmology Clinic', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Takeda Eye Clinic'}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Kanamori Eye Clinic', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Dannoue Eye Clinic', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Hodogaya iina Eye Clinic', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Honda Eye Clinic', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Yokosuka Chuoh Eye Clinic', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Kengun Sakuragi Eye Clinic', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Miyagi', 'country': 'Japan', 'facility': 'Hideyuki Eye Clinic', 'geoPoint': {'lat': 26.62566, 'lon': 128.18236}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Iwashita Eye Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Maeda Eye Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Nishi Eye Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'OCROM Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Onoe Eye Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Sugasawa Eye Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Sugiura Eye Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Tahara Eye Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Tane Memorial Eye Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Kawaguchi Aozora Eye Clinic', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Omiya Hamada Eye Clinic West entrance Branch', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Omiya Hamada Eye Clinic', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Shibuya Ophthalmology Clinic', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Muramatsu Eye Clinic', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Nakamura Eye Clinic', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Ono Ophthalmic Clinic', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Saito Eye Clinic', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Yoshimura Eye & Internal Medical Clinic', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Dogenzaka Kato Eye Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Hashida Eye Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Kakinoki Eye Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Seijo Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Shimizu Eye Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Shirayama Eye Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Suitengu Fujita Ophthalmo Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tamagawa Eye Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokiwadai Muranaka Eye Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Ueda Eye Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Watanabe Eye Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Yamanashi', 'country': 'Japan', 'facility': 'IMAI Eye Clinic', 'geoPoint': {'lat': 35.67152, 'lon': 138.69827}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}