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

NCT00198419

ISTA-VIT-CS04

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 10% hypersensitivity response was considered acceptable.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Vitrase

Experimental group

Description:

a single intradermal dose of 3 USP Units of Vitrase (ovine hyaluronidase) at one site and the same volume of saline at a distant site for comparative control

Treatment:

Drug: Vitrase