Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT01670357
Status:
COMPLETED
Last Update Posted:
2014-10-01
First Post:
2012-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of DA-6034 Eye Drops in 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': 'C121889', 'term': 'recoflavone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-29', 'studyFirstSubmitDate': '2012-01-19', 'studyFirstSubmitQcDate': '2012-08-19', 'lastUpdatePostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of Fluorescein Corneal Staining(FCS) score', 'timeFrame': '4 weeks', 'description': 'Change from baseline means the change between 0 weeks and 4 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline of Tear Break-Up Time(TBUT)', 'timeFrame': '4 weeks', 'description': 'Change from baseline means the change between 0 weeks and 4 weeks.'}, {'measure': 'Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score', 'timeFrame': '4 weeks', 'description': 'Change from baseline means the change between 0 weeks and 4 weeks.'}, {'measure': 'Change from baseline of Schirmer Test I score', 'timeFrame': '4 weeks', 'description': 'Change from baseline means the change between 0 weeks and 4 weeks.'}, {'measure': 'Change from baseline of Ocular Surface Disease Index(OSDI) score', 'timeFrame': '4 weeks', 'description': 'Change from baseline means the change between 0 weeks and 4 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry Eye Syndrome'], 'conditions': ['Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared with placebo in dry eye syndrome.', 'detailedDescription': 'Eligible subjects are randomly assigned to receive 3% DA-6034, 5% DA-6034 or Placebo. This study is conducted for 6 weeks(Run-in Period 2 weeks + Treatment Period 4 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age≥20\n2. Dry eye symptoms(irritation, foreign body sensation, burning, mucus discharge, blurring, itching, photophobia, tird or heavy feeling, pain) for more than 6 months\n3. Fluorescein corneal staining score ≥ 4 and Schirmer test I ≤ 7mm in same eye\n4. Corrected vision ≥ 0.2 in both eye\n5. Have given a written, informed consent\n\nExclusion Criteria:\n\n1. Ocular disorder that may confound interpretation of study results\n2. Current treatment for glaucoma or IOP over 25mmHg\n3. Ocular surgery history within 1 year\n4. Other malignancy history or uncontrolled severe disease within 5 years\n5. Use of systemic immunosuppressive therapies within 3 months\n6. Use of opthalmic cyclosporin, opthalmic steroid within 4 weeks\n7. Received any other investigational drugs within 4 weeks\n8. Subjects who are willing to wear contact lenses during study participation\n9. Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01670357', 'acronym': 'DES', 'briefTitle': 'Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'Placebo Controlled, Dose-Response, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of DA-6034 Eye Drops in Patients With Dry Eye Syndrome', 'orgStudyIdInfo': {'id': 'DA6034_DES_II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DA-6034 Low dose', 'description': 'DA-6034 3%', 'interventionNames': ['Drug: DA-6034 3%']}, {'type': 'EXPERIMENTAL', 'label': 'DA-6034 High dose', 'description': 'DA-6034 5%', 'interventionNames': ['Drug: DA-6034 5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'DA-6034 Placebo', 'interventionNames': ['Drug: DA-6034 Placebo']}], 'interventions': [{'name': 'DA-6034 3%', 'type': 'DRUG', 'otherNames': ['DA-6034 Low dose'], 'description': 'Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks', 'armGroupLabels': ['DA-6034 Low dose']}, {'name': 'DA-6034 5%', 'type': 'DRUG', 'otherNames': ['DA-6034 High dose'], 'description': 'Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks', 'armGroupLabels': ['DA-6034 High dose']}, {'name': 'DA-6034 Placebo', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St.Mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'ManSoo Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}