Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198458
Status:
COMPLETED
Last Update Posted:
2013-03-18
First Post:
2005-09-13
Brief Title:
Hypersensitivity Reaction to Vitrase Ovine Hyaluronidase
Sponsor:
Bausch Lomb Incorporated
Organization:
Bausch Lomb Incorporated
Study Overview
Official Title:
Clinical Evaluation of Hypersensitivity Reaction to Vitrase Ovine Hyaluronidase 150 USP UnitsmL Open Label Normal Volunteer Study
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 a 10 hypersensitivity response was considered acceptable
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None