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NCT00198458 Clinical Trial

Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Drug Hypersensitivity Clinical Trial

Official title:
Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00198458
Other study ID # ISTA-VIT-CS05
Secondary ID
Status Completed
Phase Phase 1
First received September 13, 2005
Last updated March 14, 2013
Start date July 2004
Est. completion date September 2004

Study information
Verified date March 2013
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date September 2004
Est. primary completion date July 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Vitrase

Locations
Country Name City State
United States Solano Clinical Research (A Division of Dow Pharmaceutical Sciences) Davis California

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hypersensitivity Incidence of hypersensitivity to Vitrase following a single intradermal injection of 4.5 USP units Vitrase. 1-2 days No
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