Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-01-22 @ 12:22 AM
Study NCT ID:
NCT01804361
Status:
COMPLETED
Last Update Posted:
2015-07-22
First Post:
2013-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Haporine-S for Treatment of Moderate to Severe Dry Eye Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003524', 'term': 'Cyclosporins'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-20', 'studyFirstSubmitDate': '2013-02-27', 'studyFirstSubmitQcDate': '2013-03-04', 'lastUpdatePostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '1 year', 'description': 'Adverse Event will be assessed for the whole study period(1 year).'}, {'measure': 'Serious Adverse Events', 'timeFrame': '1 year', 'description': 'Serious Adverse Event will be assessed for the whole study period(1 year).'}], 'primaryOutcomes': [{'measure': 'Corneal staining', 'timeFrame': 'up to 12 weeks', 'description': 'Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'Ocular Surface Disease Index(OSID)', 'timeFrame': '0 day, 4 weeks and 12 weeks', 'description': 'Ocular Surface Disease Index(OSID) will be assessed at 0 day, 4 weeks and 12 weeks.'}, {'measure': 'Tear Breakup Time(TBUT)', 'timeFrame': '0 day, 4 weeks and 12 weeks', 'description': 'Tear Breakup Time(TBUT) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.'}, {'measure': 'Schirmer score', 'timeFrame': '0 day, 4 weeks and 12 weeks', 'description': 'Schirmer score will be assessed at 0 day(baseline), 4 weeks and 12 weeks.'}, {'measure': 'Drug compliance', 'timeFrame': '0 day, 4 weeks and 12 weeks', 'description': 'Drug compliance(conjunctival hyperemia and burning etc) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.'}, {'measure': 'DEWS(Dry Eye WorkShop) level', 'timeFrame': '0 day, 4 weeks and 12 weeks', 'description': 'Level on dry eye severity grading scheme of DEWS will be assessed at 0 day(baseline), 4 weeks and 12 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry Eye Syndromes'], 'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine efficacy and safety of Haporine-S eye drop for the patients with moderate to severe dry eye disease in a multicenter phase III clinical trial.', 'detailedDescription': 'This study is to compare the efficacy and the safety of topical Haposine-S and Restasis® eye drop 0.05% for the patients with moderate to severe dry eye disease in a multicenter, investigator(assessor) blind, parallel design, non-inferiority phase III trial.\n\nPrimary outcome is the change of corneal staining score(Oxford scheme) at 12 weeks from baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age 20 or over\n* Patients with moderate to severe dry eye(DEWS Level II or over)\n* Be informed of the nature of the study and will give written informed consent\n\nExclusion Criteria:\n\n* Being treated with steroidal eye drop or non-steroidal anti-inflammatory eye drop for dry eye\n* Being treated with systemic steroid or immunosuppressive\n* History of eyeball surgical operation within 6 months\n* Wearing contact lenses during participation of the study\n* Pregnancy or breastfeeding\n* Use of cyclosporine eye drop within 2 weeks\n* Intraocular pressure(IOP)\\> 25 mmHg\n* History of punctal occlusion within 1 month or during participation of the study\n* Hypersensitivity to the investigational products or be suspicious to them\n* Patients whom the investigator considers inappropriate to participate in the study'}, 'identificationModule': {'nctId': 'NCT01804361', 'briefTitle': 'Efficacy and Safety Study of Haporine-S for Treatment of Moderate to Severe Dry Eye Syndromes', 'organization': {'class': 'INDUSTRY', 'fullName': 'DH Bio Co., Ltd.'}, 'officialTitle': 'Efficacy and Safety Study of Haporine-S in Subjects With Moderate to Severe Dry Eye, A Multicenter, Investigator(Assessor)Blind, Parallel Design, Non-inferiority Phase III Trial', 'orgStudyIdInfo': {'id': 'UMT-2012-DH-HS-01'}, 'secondaryIdInfos': [{'id': '1360-8040-3073-4190', 'type': 'OTHER', 'domain': 'Korea Food and Drug Administration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Haporine-S', 'description': 'Moderate to severe dry patients administered with with Haporine-S', 'interventionNames': ['Drug: Haporine-S']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restasis, Cyclosporine 0.05%', 'description': 'Moderate to severe dry eye patients with Restasis(cyclosporine 0.05%)', 'interventionNames': ['Drug: Restasis (cyclosporine 0.05%)']}], 'interventions': [{'name': 'Haporine-S', 'type': 'DRUG', 'description': '1 or 2 drops twice a day at 12 hour interval for 12 weeks', 'armGroupLabels': ['Haporine-S']}, {'name': 'Restasis (cyclosporine 0.05%)', 'type': 'DRUG', 'description': '1 or 2 drops twice a day at 12 hour interval for 12 weeks', 'armGroupLabels': ['Restasis, Cyclosporine 0.05%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '602-739', 'city': 'Busan', 'state': 'Busan', 'country': 'South Korea', 'facility': 'Busan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '110-744', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-720', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '136-705', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '152-703', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hyo-Myung KIM, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}, {'name': 'Jong Suk SONG, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Guro Hospital'}, {'name': 'Hyung Keun LEE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University Gangnam Severance Hospital'}, {'name': 'Jong-Soo LEE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Busan National University Hospital'}, {'name': 'Mee Kum KIM, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Myoung-Joon KIM, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DH Bio Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BTO Pharm. Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}