Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Phase 1

Completed

• Conditions: Drug Hypersensitivity
• Interventions: Drug: Vitrase

• Registration Number: NCT00198419
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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 10% hypersensitivity response was considered acceptable.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitrase	Vitrase	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

Primary Outcome Measures

Name	Time	Method
Hypersensitivity	1-2 days	hypersensitivity to Vitrase following a single intradermal injection of 3 USP Units Vitrase

Trial Locations

Locations (1)

Solano Clinical Research (A Division of Dow Pharmaceutical Sciences); 🇺🇸 Davis, California, United States