Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT00198458
Status:
COMPLETED
Last Update Posted:
2013-03-18
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004342', 'term': 'Drug Hypersensitivity'}], 'ancestors': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002810', 'term': 'Chondroitinases and Chondroitin Lyases'}], 'ancestors': [{'id': 'D013429', 'term': 'Sulfatases'}, {'id': 'D004950', 'term': 'Esterases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D011133', 'term': 'Polysaccharide-Lyases'}, {'id': 'D019757', 'term': 'Carbon-Oxygen Lyases'}, {'id': 'D008190', 'term': 'Lyases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-14', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2013-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypersensitivity', 'timeFrame': '1-2 days', 'description': 'Incidence of hypersensitivity to Vitrase following a single intradermal injection of 4.5 USP units Vitrase.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Drug Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to a 10% hypersensitivity response was considered acceptable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Agreed to avoid disallowed meds\n\nExclusion Criteria:\n\n* Known hypersensitivity to hyaluronidase and/or bee sting\n* Previous known exposure to ovine hyaluronidase or bovine hyaluronidase\n* Atopic individuals assessed by medical history\n* Topical/inhaled/systemic corticosteroids within 30 days\n* Concurrent use of antihistamines or anti-inflammatory during study\n* Active or chronic disease likely to affect immune function\n* History of alcohol/drug abuse within 6 months'}, 'identificationModule': {'nctId': 'NCT00198458', 'briefTitle': 'Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study', 'orgStudyIdInfo': {'id': 'ISTA-VIT-CS05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitrase', 'description': 'A single intradermal dose of 4.5 USP units of Vitrase at one site and the same volume of saline at a distant site for comparative control.', 'interventionNames': ['Drug: Vitrase']}], 'interventions': [{'name': 'Vitrase', 'type': 'DRUG', 'otherNames': ['ovine hyaluronidase'], 'armGroupLabels': ['Vitrase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}], 'overallOfficials': [{'name': 'Lisa R Grillone, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ISTA Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}