Overview

Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Status:
Completed
Trial end date:
2004-09-01
Target enrollment:
0
Participant gender:
All
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 a 10% hypersensitivity response was considered acceptable.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bausch & Lomb Incorporated
Criteria
Inclusion Criteria:

- Agreed to avoid disallowed meds

Exclusion Criteria:

- Known hypersensitivity to hyaluronidase and/or bee sting

- Previous known exposure to ovine hyaluronidase or bovine hyaluronidase

- Atopic individuals assessed by medical history

- Topical/inhaled/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