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