Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-14 @ 3:52 PM
Study NCT ID:
NCT04041856
Status:
UNKNOWN
Last Update Posted:
2019-08-01
First Post:
2019-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-08-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-11-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2019-07-24', 'studyFirstSubmitQcDate': '2019-07-30', 'lastUpdatePostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis', 'timeFrame': '3 months', 'description': "Decreased patient's symptoms"}, {'measure': 'Povidone-iodine 2% eye drop', 'timeFrame': '3 months', 'description': 'Decreased viral load based on PCR results'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adenoviral Keratoconjunctivitis']}, 'descriptionModule': {'briefSummary': 'Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis', 'detailedDescription': 'Diagnosed EKC patients will be devided into two groups,first group will undergo povidone-iodine 2% eye drop four times a day and the control group will be treated only by artificial tear drops,they will be examined 3 months later and evaluations and data collections for the final comparison will be done.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suspected for viral conjunctivitis\n\nExclusion Criteria:\n\n* Allergic to iodized materials\n* Age under 17'}, 'identificationModule': {'nctId': 'NCT04041856', 'briefTitle': 'Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis', 'organization': {'class': 'OTHER', 'fullName': 'Farabi Eye Hospital'}, 'officialTitle': 'Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis', 'orgStudyIdInfo': {'id': 'farabieyehospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EKC patients', 'description': 'Povidone-iodine 2% eye drop will be prescribed four times a day All patients will learn how to improve the hygiene level in order to reduce transmission', 'interventionNames': ['Drug: Povidone Ophthalmic']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'All patients will undergo observational treatments including artificial tear drop and improving hygiene level'}], 'interventions': [{'name': 'Povidone Ophthalmic', 'type': 'DRUG', 'otherNames': ['Povidone-iodine 2%'], 'description': 'Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis', 'armGroupLabels': ['EKC patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohammad Soleimani, professor', 'role': 'CONTACT', 'email': 'Soleimani_md@yahoo.com', 'phone': '00989121096496'}, {'name': 'Arash Mirzaei, Resident', 'role': 'CONTACT', 'email': 'drarashmirzaei@gmail.com', 'phone': '00989126424299'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Farabi Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of ophthalmology', 'investigatorFullName': 'mohammad soleimani', 'investigatorAffiliation': 'Farabi Eye Hospital'}}}}