drugset / Trial / NCT00198458

Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

NCT00198458 ↗

Phase 1 Completed 65 enrolled Bausch & Lomb Incorporated
NaSingle-groupOpen-label

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.

Timeline

Start
2004-07
Primary completion
2004-07
Completion
2004-09

Drugs

EvaluationDrugModalityDoseRoute
Subject HYALURONIDASE (OVINE) Protein / enzyme biologic 4.5 unknown Other