Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT03762369
Status:
UNKNOWN
Last Update Posted:
2018-12-03
First Post:
2018-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Efficacy and Safety of CKD-351
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'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 384}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-30', 'studyFirstSubmitDate': '2018-11-14', 'studyFirstSubmitQcDate': '2018-11-30', 'lastUpdatePostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety assessed by number of participants with treatment-related adverse events', 'timeFrame': 'up to 24 weeks'}], 'primaryOutcomes': [{'measure': 'Change in mean intraocular pressure at 12 weeks compared to baseline', 'timeFrame': 'Baseline, 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in mean intraocular pressure at 4 weeks, 8weeks compared to baseline', 'timeFrame': 'Baseline, 4 weeks, 8 weeks'}, {'measure': 'Changes in intraocular pressure by measurement time', 'timeFrame': '4 weeks, 8 weeks, 12 weeks', 'description': 'IOP variation by measurement time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Open-angle Glaucoma', 'Ocular Hypertension', 'CKD-351'], 'conditions': ['Primary Open-angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy and safety of CKD-351.', 'detailedDescription': 'Multi center, Randomized, Double-blind, Active controlled, Parallel design, Phase 3 trial to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular hypertension patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. More than the age of 19 years old\n2. Subjects who has primary Open-Angle Glaucoma or Ocular Hypertension\n3. Subjects who sign on an informed consent form willingly\n\nExclusion Criteria:\n\n1. Subjects with IOP(Intraocular Pressure) ≥35 mmHg at Visit 1 and Visit 2 (AM 09:00) at more than one eye\n2. Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 2\n3. Subjects who were diagnosed as below with monocular or both eye\n\n * Acute or Chronic Closed-Angle Glaucoma\n * Secondary Glaucoma\n * Pseudoexfoliation Glaucoma\n * Neovascular Glaucoma\n * Aphakia\n * Phacocyst capsular torn intraocular lens\n4. Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation ≥ -25dB)\n5. Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)\n6. Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months\n7. Subjects who have medical history following\n\n * Subjects with significant history of ocular trauma during the last 6 months, or who underwent surgical ophthalmic surgery\n * Subjects who received topical or systemic steroids within the last 1 months\n8. Subjects who wore need to wear contact lenses during the study\n9. Women who are nursing, pregnant or planning pregnancy during the study\n10. Subjects with bronchial asthma or history\n11. Subjects with severe renal impairment (creatinine clearance \\<30 ml / min at screening) or hyperchloremic acidosis\n12. Subjects who have received any other investigational product within 1 month prior to randomization\n13. Impossible subjects who participate in clinical trial by investigator's decision"}, 'identificationModule': {'nctId': 'NCT03762369', 'briefTitle': 'A Clinical Study to Evaluate the Efficacy and Safety of CKD-351', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Multi Center, Randomized, Double-blind, Active Controlled, Parallel Design, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-351 in Primary Open Angle Glaucoma or Ocular Hypertension Patients', 'orgStudyIdInfo': {'id': '171GLC18006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CKD-351', 'description': 'Latanoprost+D930', 'interventionNames': ['Drug: CKD-351', 'Drug: D930']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Latanoprost', 'interventionNames': ['Drug: Latanoprost', 'Drug: Placebo of CKD-351', 'Drug: Placebo of D930']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D930', 'interventionNames': ['Drug: D930', 'Drug: Placebo of CKD-351']}], 'interventions': [{'name': 'CKD-351', 'type': 'DRUG', 'otherNames': ['Latanoprost+D930'], 'description': 'twice a day', 'armGroupLabels': ['CKD-351']}, {'name': 'Latanoprost', 'type': 'DRUG', 'description': 'once a day', 'armGroupLabels': ['Latanoprost']}, {'name': 'D930', 'type': 'DRUG', 'description': 'three times a day', 'armGroupLabels': ['CKD-351', 'D930']}, {'name': 'Placebo of CKD-351', 'type': 'DRUG', 'description': 'once a day', 'armGroupLabels': ['Latanoprost']}, {'name': 'Placebo of CKD-351', 'type': 'DRUG', 'description': 'twice a day', 'armGroupLabels': ['D930']}, {'name': 'Placebo of D930', 'type': 'DRUG', 'description': 'three times a day', 'armGroupLabels': ['Latanoprost']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Jongno', 'country': 'South Korea', 'facility': 'Seoul National University Hosipital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'KiHo Park', 'role': 'CONTACT', 'email': 'kihopark@snu.ac.kr', 'phone': '82-10-3458-3172'}], 'overallOfficials': [{'name': 'KiHo Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hosipital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}