Clinical Trials Directory

Trials / Completed

CompletedNCT00198419

Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase) Open Label, Normal Volunteer Study

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
65 (actual)
Sponsor
Bausch & Lomb Incorporated · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGVitrase

Timeline

Start date
2004-03-01
Primary completion
2004-03-01
Completion
2004-03-01
First posted
2005-09-20
Last updated
2013-03-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00198419. Inclusion in this directory is not an endorsement.