Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-02-27 @ 12:49 AM
Study NCT ID:
NCT02917512
Status:
COMPLETED
Last Update Posted:
2018-04-12
First Post:
2016-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-10', 'studyFirstSubmitDate': '2016-09-26', 'studyFirstSubmitQcDate': '2016-09-26', 'lastUpdatePostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from Baseline of Corneal staining score - Oxford grading', 'timeFrame': 'Week 12'}], 'secondaryOutcomes': [{'measure': 'change from Baseline of Corneal staining score - Oxford grading', 'timeFrame': 'Week 4, 8'}, {'measure': 'change from Baseline of Strip meniscometry assessment', 'timeFrame': 'Week 4, 8, 12'}, {'measure': 'change from Baseline of Tear film break-up time', 'timeFrame': 'Week 4, 8, 12'}, {'measure': 'change from Baseline of Standard patient evaluation of eye dryness questionnaire', 'timeFrame': 'Week 4, 8, 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndrome']}, 'referencesModule': {'references': [{'pmid': '33449860', 'type': 'DERIVED', 'citation': 'Shin J, Rho CR, Hyon JY, Chung TY, Yoon KC, Joo CK. A Randomized, Placebo-Controlled Phase II Clinical Trial of 0.01% or 0.02% Cyclosporin A with 3% Trehalose in Patients with Dry Eye Disease. J Ocul Pharmacol Ther. 2021 Jan-Feb;37(1):4-11. doi: 10.1089/jop.2020.0104.'}]}, 'descriptionModule': {'briefSummary': 'A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult Patients with Dry Eye Syndrome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 19\n* Corneal staining score(Oxford grading) \\> 2 or Schirmer test \\< 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test \\> 3mm/5min)\n* Volunteer who went through menopause more than 1 years ago before screening or has surgical menopause\n* Volunteer who has negative result of pregnancy test or use effective contraception\n\nExclusion Criteria:\n\n* Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status\n* The patients with systemic or ocular disorders affected the test result\n* Being treated with systemic steroid\n* Wearing contact lenses within 3 days of screening visit\n* Pregnancy or Breastfeeding'}, 'identificationModule': {'nctId': 'NCT02917512', 'briefTitle': 'Efficacy and Safety Study of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Huons Co., Ltd.'}, 'officialTitle': 'A Multicenter, Placebo Controlled, Restasis® Referenced, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome', 'orgStudyIdInfo': {'id': 'HU-007_P2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HU00701', 'description': 'HU00701(Cyclosporine 0.01% + 3% trehalose)\n\n1 drop b.i.d at 12 hour interval for 12 weeks', 'interventionNames': ['Drug: HU00701']}, {'type': 'EXPERIMENTAL', 'label': 'HU007', 'description': 'HU007(Cyclosporine 0.02% + 3% trehalose)\n\n1 drop b.i.d at 12 hour interval for 12 weeks', 'interventionNames': ['Drug: HU007']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restasis', 'description': 'Restasis(Cyclosporine 0.05%)\n\n1 drop b.i.d at 12 hour interval for 12 weeks', 'interventionNames': ['Drug: Restasis']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo(without main component)', 'description': 'Placebo\n\n1 drop b.i.d at 12 hour interval for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HU00701', 'type': 'DRUG', 'description': 'Cyclosporine 0.01% + 3% trehalose', 'armGroupLabels': ['HU00701']}, {'name': 'HU007', 'type': 'DRUG', 'description': 'Cyclosporine 0.02% + 3% trehalose', 'armGroupLabels': ['HU007']}, {'name': 'Restasis', 'type': 'DRUG', 'description': 'Cyclosporine 0.05%', 'armGroupLabels': ['Restasis']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Vehicle', 'armGroupLabels': ['Placebo(without main component)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13486', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Huons', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Seung-il Baek', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Huons Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huons Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}