Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Phase 1CompletedNCT00198458

Bausch & Lomb Incorporated65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Drug Hypersensitivity

Interventions

VitraseDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)

Davis, California, United States

Outcomes

Primary Outcomes

Hypersensitivity

Incidence of hypersensitivity to Vitrase following a single intradermal injection of 4.5 USP units Vitrase.

Time frame: 1-2 days

Data from ClinicalTrials.gov

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