Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study
| Registry | NCT00198458 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; na, single group, masking: none |
| Enrollment | 65 |
| Sponsor | Bausch & Lomb Incorporated (Industry) |
| Conditions | Drug Hypersensitivity |
| Interventions | Vitrase (Drug) |
| Dates | start 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 in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Drug Hypersensitivity All trials of Vitrase
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Vitrase | Experimental | Drug: Vitrase | A single intradermal dose of 4.5 USP units of Vitrase at one site and the same volume of saline at a distant site for comparative control. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * Agreed to avoid disallowed meds Exclusion Criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Solano Clinical Research (A Division of Dow Pharmaceutical Sciences) | Davis, California | United States |