Status:
COMPLETED
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Drug Hypersensitivity
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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% hyper...
Eligibility Criteria
Inclusion
- Avoid disallowed meds throughout study
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00198419
Start Date
March 1 2004
End Date
March 1 2004
Last Update
March 14 2013
Active Locations (1)
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1
Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)
Davis, California, United States, 95616