Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

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 10% hypersensitivity response was considered acceptable.

Full Title of Study: “Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase) Open Label, Normal Volunteer Study”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Screening
  • Masking: None (Open Label)
• Study Primary Completion Date: March 2004

Interventions

• Drug: Vitrase

Arms, Groups and Cohorts

• Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

• Hypersensitivity
  • Time Frame: 1-2 days
  • hypersensitivity to Vitrase following a single intradermal injection of 3 USP Units Vitrase

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Bausch & Lomb Incorporated
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Lisa R Grillone, PhD, Study Director, ISTA Pharmaceuticals, Inc.