Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT00988494
Status:
COMPLETED
Last Update Posted:
2012-11-22
First Post:
2009-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'lastUpdateSubmitDate': '2012-11-21', 'studyFirstSubmitDate': '2009-09-30', 'studyFirstSubmitQcDate': '2009-10-01', 'lastUpdatePostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Restoration of corneal epithelial defect', 'timeFrame': 'Every week'}], 'secondaryOutcomes': [{'measure': 'Visual acuity,etc.', 'timeFrame': 'Exit visit,etc.'}]}, 'conditionsModule': {'conditions': ['Persistent Corneal Epithelial Defect']}, 'descriptionModule': {'briefSummary': 'Safety and efficacy of DE-105 ophthalmic solution in patients with persistent corneal epithelial defect will be evaluated. Dose-dependent efficacy will be evaluated as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has corneal epithelial defect and decreased corneal sensitivity.\n* Has undergone continuous treatment for corneal epithelial defect for 1 week or longer.\n\nExclusion Criteria:\n\n* Presence of disease such as active ocular infection, or abnormal lid closure.\n* History or presence of chemical burn, Stevens - Johnson Syndrome, etc.\n* History of corneal transplantation, LASIK, or hematopoietic stem cell transplantation.'}, 'identificationModule': {'nctId': 'NCT00988494', 'briefTitle': 'Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect', 'orgStudyIdInfo': {'id': '01050807'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High concentration', 'description': 'DE-105 high concentration', 'interventionNames': ['Drug: DE-105 ophthalmic solution']}, {'type': 'EXPERIMENTAL', 'label': 'Low concentration', 'description': 'DE-105 low concentration', 'interventionNames': ['Drug: DE-105 ophthalmic solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'DE-105 placebo', 'interventionNames': ['Drug: Placebo ophthalmic solution']}], 'interventions': [{'name': 'DE-105 ophthalmic solution', 'type': 'DRUG', 'description': 'Topical ocular application', 'armGroupLabels': ['High concentration']}, {'name': 'DE-105 ophthalmic solution', 'type': 'DRUG', 'description': 'Topical ocular application', 'armGroupLabels': ['Low concentration']}, {'name': 'Placebo ophthalmic solution', 'type': 'DRUG', 'description': 'Topical ocular application', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'country': 'Japan', 'facility': 'Santen study sites', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}}}}