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 ]
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