Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 1:27 PM
Study NCT ID:
NCT04164459
Status:
UNKNOWN
Last Update Posted:
2019-11-15
First Post:
2019-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy and Safety of Xalost S in Glaucoma Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2019-10-15', 'studyFirstSubmitQcDate': '2019-11-14', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal Staining Score at week 12', 'timeFrame': 'week 12', 'description': 'At week 12 of drug administration compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on corneal staining score.\n\nScale: "Oxford grading system" that divides into 6 groups according to severity from 0 (absent) to 5 (severe).\n\nThe higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Hyperemia Score at week 4, 8, 12', 'timeFrame': 'baseline and week 4, 8, 12', 'description': 'After 4, 8, 12 weeks of drug administration compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on Hyperemia Score.\n\nScale: "Efron Grading Scales" that divided into 5 groups according to severity from 0 (normal) to 4 (severe).\n\nThe higher scores mean a worse outcome.'}, {'measure': 'Change from baseline in Intraocular Pressure at week 4, 8, 12', 'timeFrame': 'baseline and week 4, 8, 12', 'description': 'After 4, 8, 12 weeks of drug administration compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on Intraocular pressure.\n\nThe highest Intraocular pressure means a worse outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'In patients with Glaucoma, Xalost S or Xalatan or Taflotan-S are administered for 12 weeks. After 12 weeks, among them, Xalatan administration group are switched to Xalost S or Taflotan-S. Extension study period is 8 weeks.\n\nTo compare effect (ocular surface damage) and safety of preservative-free Latanoprost/Tafluprost to Benzalkonium chloride-preserved Latanoprost in primary open angle glaucoma or normal tension glaucoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female diagnosed with glaucoma, age 19 or over\n* Written informed consent to participate in the trial\n\nExclusion Criteria:\n\n* Patients who have received or have plans lacrimal puntual occulsion\n* Use of contact lenses\n* Any other Glaucoma except primary open angle glaucoma/normal tension glaucoma (ex) Closed anterior chamber angle/ angle-closure Glaucoma)\n* Any condition limiting patient's ability to participate in the trial"}, 'identificationModule': {'nctId': 'NCT04164459', 'briefTitle': 'Evaluating the Efficacy and Safety of Xalost S in Glaucoma Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taejoon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Blinded Evaluator, Active Control, Parallel, Phase IV Study to Evaluate the Efficacy and Safety of Xalost S in Glaucoma Patients.', 'orgStudyIdInfo': {'id': 'TJO-002-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xalost S', 'interventionNames': ['Drug: Xalost S']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xalatan', 'interventionNames': ['Drug: Xalatan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Taflotan-S', 'interventionNames': ['Drug: Taflotan-S']}], 'interventions': [{'name': 'Xalost S', 'type': 'DRUG', 'description': 'One drop one times a day in study eye', 'armGroupLabels': ['Xalost S']}, {'name': 'Xalatan', 'type': 'DRUG', 'description': 'One drop one times a day in study eye', 'armGroupLabels': ['Xalatan']}, {'name': 'Taflotan-S', 'type': 'DRUG', 'description': 'One drop one times a day in study eye', 'armGroupLabels': ['Taflotan-S']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Taejoon Pharmaceutical Co., Ltd.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sukyoung Kwon, PhD', 'role': 'CONTACT', 'email': 'skkwon@taejoon.co.kr', 'phone': '+82-2-799-0175'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taejoon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}