Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
Information source: ISTA Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug Hypersensitivity
Intervention: Vitrase (ovine hyaluronidase); Sterile saline (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: ISTA Pharmaceuticals Official(s) and/or principal investigator(s):
Lisa R Grillone, PhD, Study Director, Affiliation: ISTA Pharmaceuticals, Inc.
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.
Clinical Details
Official title: Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase) Open Label, Normal Volunteer Study
Study design: Cross-Sectional, Defined Population, Prospective Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Solano Clinical Research (A Division of Dow Pharmaceutical Sciences), Davis, California 95616, United States
Additional Information
Starting date: March 2004
Ending date: March 2004
Last updated: January 15, 2007
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