Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-27 @ 1:40 PM
Study NCT ID:
NCT01115192
Status:
COMPLETED
Last Update Posted:
2018-11-19
First Post:
2010-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blephacura Versus Baby Shampoo to Treat Blepharitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001762', 'term': 'Blepharitis'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-16', 'studyFirstSubmitDate': '2010-05-03', 'studyFirstSubmitQcDate': '2010-05-03', 'lastUpdatePostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Blepharitis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the effectiveness in treatment of chronic blepharitis either with a phospholipid liposome suspension compared to a conventional therapy recommendation using diluted baby shampoo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with blepharitis\n* 100 eyes of 100 patients (50 patients treated with Blephacura, 50 patients treated with diluted baby shampoo) The ratio of female / male is not involved.\n\nExclusion Criteria:\n\n* all patients that are not included in the group of inclusion criteria'}, 'identificationModule': {'nctId': 'NCT01115192', 'briefTitle': 'Blephacura Versus Baby Shampoo to Treat Blepharitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Blephacura Versus Baby Shampoo to Treat Blepharitis', 'orgStudyIdInfo': {'id': 'OptimaCologne'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Patients with chronic blepharitis, that will be treated with blephacura', 'interventionNames': ['Procedure: Group A']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Patients with chronic blepharitis that will be treated with diluted baby shampoo', 'interventionNames': ['Procedure: Group B']}], 'interventions': [{'name': 'Group A', 'type': 'PROCEDURE', 'description': 'Blephacura is a solution with liposomes and used for cleaning of the eye lid to treat blepharitis', 'armGroupLabels': ['Group A']}, {'name': 'Group B', 'type': 'PROCEDURE', 'description': 'Diluted Baby Shampoo is used for cleaning of the eye lid to treat blepharitis', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Eye Hospital, University of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Optima Pharmazeutische GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Blephacura Versus Baby Shampoo to Treat Blepharitis', 'investigatorFullName': 'Arno Hueber', 'investigatorAffiliation': 'University of Cologne'}}}}