Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT04637633
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2020-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical Cyclosporine-A for Management of Epiphora
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003524', 'term': 'Cyclosporins'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-19', 'studyFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2020-11-15', 'lastUpdatePostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epiphora grading', 'timeFrame': '3 months', 'description': 'Munk grading system score from 0 to 5 the higher the worse'}], 'secondaryOutcomes': [{'measure': 'Fluorescein dye disappearance test (FDT)', 'timeFrame': '3 months', 'description': 'via installing a drop of 2% fluorescein and asses the height of the tear film in millimeters'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cyclosporine A', 'Epiphora', 'punctal stenosis'], 'conditions': ['Epiphora']}, 'descriptionModule': {'briefSummary': 'to investigate the clinical outcomes and tolerances of Cyclosporine A (CsA) in treating epiphora in eyes with acquired punctum stenosis', 'detailedDescription': 'a prospective study included patients who were referred to our outpatient clinics in Farwanyia hospital, Kuwait during the period between July 2019 and January 2020, having symptomatic epiphora associated with severe acquired lower punctal stenosis. Patients were treated with topical 0.05% CsA on twice daily dose with topical preservative free artificial tears Q.I. D. Patients were followed up monthly for at least 3 months by epiphora grading, Fluorescein dye disappearance test (FDT) and evaluating the patient satisfaction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients of either sex\n* had a diagnosis of epiphora that persisted more than three months both indoors and outdoors\n* grade 0 punctal stenosis\n* did not adequately respond to artificial tears, topical corticosteroids and topical antibiotics or in whom corticosteroids were discontinued due to their side effects.\n\nExclusion Criteria:\n\n* congenital punctal obstruction\n* edematous puncti\n* allergic conjunctivitis\n* history of dacryocystitis,\n* inflammatory systemic diseases\n* any previous chemotherapy treatment, and local irradiation.\n* other causes of epiphora, lid laxity, entropion, and ectropion\n* lid malposition, canalicular or nasolacrimal sac or duct obstruction\n* previous eyelid or lacrimal drainage surgery\n* untreated conjunctivitis or blepharitis'}, 'identificationModule': {'nctId': 'NCT04637633', 'acronym': 'CSA-epiphora', 'briefTitle': 'Topical Cyclosporine-A for Management of Epiphora', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Farwaniya Hospital'}, 'officialTitle': 'Topical Cyclosporine-A for Management of Epiphora in Eyes With Acquired Punctal Stenosis', 'orgStudyIdInfo': {'id': 'Farwanyia Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyclosporine A', 'description': 'All patients were treated with topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California) on twice daily dose, in addition to the topical preservative free artificial tears Q.I. D.', 'interventionNames': ['Drug: topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,']}], 'interventions': [{'name': 'topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,', 'type': 'DRUG', 'otherNames': ['preservative free artificial tears'], 'description': 'topical preservative free artificial tears Q.I. D.', 'armGroupLabels': ['Cyclosporine A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuwait City', 'state': 'Farwanyia', 'country': 'Kuwait', 'facility': 'Farwanyia Hospital', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Farwaniya Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of ophthalmology Mansoura University Egypt currentlty working as senior registrar in Farwaniya Hospital', 'investigatorFullName': 'Mona A Nassief', 'investigatorAffiliation': 'Farwaniya Hospital'}}}}