Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT01016158
Status:
COMPLETED
Last Update Posted:
2009-11-19
First Post:
2009-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Umbilical Cord Serum Eye Drops
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-18', 'studyFirstSubmitDate': '2009-11-18', 'studyFirstSubmitQcDate': '2009-11-18', 'lastUpdatePostDateStruct': {'date': '2009-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Umbilical cord serum', 'Recurrent corneal erosion'], 'conditions': ['Recurrent Corneal Erosion']}, 'referencesModule': {'references': [{'pmid': '16633024', 'type': 'RESULT', 'citation': 'Yoon KC, Im SK, Park YG, Jung YD, Yang SY, Choi J. Application of umbilical cord serum eyedrops for the treatment of dry eye syndrome. Cornea. 2006 Apr;25(3):268-72. doi: 10.1097/01.ico.0000183484.85636.b6.'}, {'pmid': '12410036', 'type': 'RESULT', 'citation': 'del Castillo JM, de la Casa JM, Sardina RC, Fernandez RM, Feijoo JG, Gomez AC, Rodero MM, Sanchez JG. Treatment of recurrent corneal erosions using autologous serum. Cornea. 2002 Nov;21(8):781-3. doi: 10.1097/00003226-200211000-00010.'}, {'pmid': '17382396', 'type': 'RESULT', 'citation': 'Yoon KC, You IC, Im SK, Jeong TS, Park YG, Choi J. Application of umbilical cord serum eyedrops for the treatment of neurotrophic keratitis. Ophthalmology. 2007 Sep;114(9):1637-42. doi: 10.1016/j.ophtha.2006.12.014. Epub 2007 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'In the present study, the investigators investigated the efficacy of umbilical cord serum eye drops for the treatment of patients with recurrent corneal erosions. Group A were treated with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears, and group B were treated with artificial tears only. Ophthalmic examinations including visual acuity measurement and slit lamp biomicroscopy were performed before and every month after treatment. Recurrence was defined as the presence of clinical symptoms accompanied by epithelial defects in the cornea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with recurrent corneal erosions\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01016158', 'briefTitle': 'Umbilical Cord Serum Eye Drops', 'organization': {'class': 'OTHER', 'fullName': 'Chonnam National University Hospital'}, 'orgStudyIdInfo': {'id': 'I-2009-11-135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'umbilical cord serum eyedrops', 'description': 'patients with recurrent corneal erosions were treated with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears', 'interventionNames': ['Drug: Umbilical cord serum eyedrops']}], 'interventions': [{'name': 'Umbilical cord serum eyedrops', 'type': 'DRUG', 'description': '20% umbilical cord serum eye drops 3 to 4 times a day', 'armGroupLabels': ['umbilical cord serum eyedrops']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kyung-Chul Yoon'}}}}