Trials / Completed
CompletedNCT00198458
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 65 (planned)
- 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 a 10% hypersensitivity response was considered acceptable.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vitrase |
Timeline
- Start date
- 2004-07-01
- Primary completion
- 2004-07-01
- Completion
- 2004-09-01
- First posted
- 2005-09-20
- Last updated
- 2013-03-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00198458. Inclusion in this directory is not an endorsement.