Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Bausch + Lomb

Status and phase: Completed; Phase 1

Conditions: Drug Hypersensitivity

Treatments: Drug: Vitrase

Study type: Interventional

Funder types: Industry

Identifiers

NCT00198458

ISTA-VIT-CS05

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

65 participants in 1 patient group

Vitrase

Experimental group

Description:

A single intradermal dose of 4.5 USP units of Vitrase at one site and the same volume of saline at a distant site for comparative control.

Treatment:

Drug: Vitrase