Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Completed · Phase 1

Conditions studied: Drug Hypersensitivity

In brief

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 a 10% hypersensitivity response was considered acceptable.

Key facts

Study ID

NCT00198458

Run by

Bausch & Lomb Incorporated

People needed

65

Starts

2004-07-01

Expected to finish

2004-09-01

Last updated by the study team

2013-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Agreed to avoid disallowed meds

You may not qualify if…

• Known hypersensitivity to hyaluronidase and/or bee sting
• Previous known exposure to ovine hyaluronidase or bovine hyaluronidase
• Atopic individuals assessed by medical history
• Topical/inhaled/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

Where it is running

• Solano Clinical Research (A Division of Dow Pharmaceutical Sciences) — Davis, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.