Clinical Trial: Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study

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 Summary:
Sponsor: Bausch & Lomb Incorporated

Current Primary Outcome: Hypersensitivity [ Time Frame: 1-2 days ]

hypersensitivity to Vitrase following a single intradermal injection of 3 USP Units Vitrase


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bausch & Lomb Incorporated

Dates:
Date Received: September 13, 2005
Date Started: July 2004
Date Completion:
Last Updated: March 13, 2013
Last Verified: March 2013