Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT01179412
Status:
COMPLETED
Last Update Posted:
2010-08-11
First Post:
2010-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003236', 'term': 'Conjunctivitis, Viral'}], 'ancestors': [{'id': 'D015828', 'term': 'Eye Infections, Viral'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011206', 'term': 'Povidone-Iodine'}], 'ancestors': [{'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-10', 'studyFirstSubmitDate': '2010-07-18', 'studyFirstSubmitQcDate': '2010-08-10', 'lastUpdatePostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the recovery rate within one week of treatment', 'timeFrame': '1 week'}], 'secondaryOutcomes': [{'measure': 'drug tolerability', 'timeFrame': '1 week', 'description': 'proportion of patient who can continue topical application of povidone-iodine for a week or until EKC subsides'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Viral Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the outcomes of treating epidemic keratoconjunctivitis with 2% povidone-iodine.', 'detailedDescription': 'The study design was a prospective interventional case series. Our institutional ethical committee approved the study protocol in April 2004. We performed this study between July 2004 and December 2009. During this period, there were 2 episodes of EKC epidemic. The first episode was in 2006 and the second in 2009.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who were diagnosed with EKC at the outpatient ophthalmic unit\n\nExclusion Criteria:\n\n* children younger than six years\n* women being pregnant or during lactation\n* history of allergy to povidone-iodine\n* prior ocular surgery\n* contact lens usage and chronic eye diseases with current eye medications.'}, 'identificationModule': {'nctId': 'NCT01179412', 'briefTitle': 'Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine', 'orgStudyIdInfo': {'id': 'EKC2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2% povidone-iodine', 'interventionNames': ['Drug: 2% povidone-iodine']}], 'interventions': [{'name': '2% povidone-iodine', 'type': 'DRUG', 'otherNames': ['PVP-I'], 'description': 'apply 4 times a day for one week', 'armGroupLabels': ['2% povidone-iodine']}, {'name': '2% povidone-iodine', 'type': 'DRUG', 'otherNames': ['PVP-I'], 'description': 'apply 2% povidone-iodine 4 times per day for one week', 'armGroupLabels': ['2% povidone-iodine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkoknoi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Ophthalmology, Siriraj Hospital Mahidol University'}], 'overallOfficials': [{'name': 'Adisak Trinavarat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Adisak Trinavara t/ Associate Professor', 'oldOrganization': 'Department of Ophthalmology, Siriraj Hospital Mahidol University'}}}}