Back to resultsHypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
Primary Purpose
Drug Hypersensitivity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitrase
Sponsored by
About this trial
This is an interventional screening trial for Drug Hypersensitivity
Eligibility Criteria
Inclusion Criteria: Avoid disallowed meds throughout study Exclusion Criteria: Known hypersensitivity to hyaluronidase and/or bee sting Atopic individuals assessed by med history Topical/systemic corticosteroids within 30 days Concurrent use of antihistamines or anti-inflammatory during study Active or chronic disease likely to affect immune function History of alcohol/drug abuse within 6 months
Sites / Locations
- Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vitrase
Arm Description
a single intradermal dose of 3 USP Units of Vitrase (ovine hyaluronidase) at one site and the same volume of saline at a distant site for comparative control
Outcomes
Primary Outcome Measures
Hypersensitivity
hypersensitivity to Vitrase following a single intradermal injection of 3 USP Units Vitrase
Secondary Outcome Measures
Full Information
NCT ID
NCT00198419
First Posted
September 13, 2005
Last Updated
March 13, 2013
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00198419
Brief Title
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
Official Title
Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase) Open Label, Normal Volunteer Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 10% hypersensitivity response was considered acceptable.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Hypersensitivity
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitrase
Arm Type
Experimental
Arm Description
a single intradermal dose of 3 USP Units of Vitrase (ovine hyaluronidase) at one site and the same volume of saline at a distant site for comparative control
Intervention Type
Drug
Intervention Name(s)
Vitrase
Other Intervention Name(s)
ovine hyaluronidase
Primary Outcome Measure Information:
Title
Hypersensitivity
Description
hypersensitivity to Vitrase following a single intradermal injection of 3 USP Units Vitrase
Time Frame
1-2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Avoid disallowed meds throughout study
Exclusion Criteria:
Known hypersensitivity to hyaluronidase and/or bee sting
Atopic individuals assessed by med history
Topical/systemic corticosteroids within 30 days
Concurrent use of antihistamines or anti-inflammatory during study
Active or chronic disease likely to affect immune function
History of alcohol/drug abuse within 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa R Grillone, PhD
Organizational Affiliation
ISTA Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
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