Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

This study has been completed.

Sponsored by:	ISTA Pharmaceuticals
Information provided by:	ISTA Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00198419

Purpose

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 10% hypersensitivity response was considered acceptable.

Condition	Intervention	Phase
Drug Hypersensitivity	Drug: Vitrase (ovine hyaluronidase); Sterile saline	Phase I

MedlinePlus related topics: Allergy

Drug Information available for: Sodium chloride Hyaluronidase

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cross-Sectional, Defined Population, Prospective Study
Official Title:	Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase) Open Label, Normal Volunteer Study

Further study details as provided by ISTA Pharmaceuticals:

Estimated Enrollment:	65
Study Start Date:	March 2004
Estimated Study Completion Date:	March 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Avoid disallowed meds throughout study

Exclusion Criteria:

Known hypersensitivity to hyaluronidase and/or bee sting
Atopic individuals assessed by med history
Topical/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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198419

Locations

United States, California
Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)
Davis, California, United States, 95616

Sponsors and Collaborators

ISTA Pharmaceuticals

Investigators

Study Director:

Lisa R Grillone, PhD

ISTA Pharmaceuticals, Inc.

More Information

Study ID Numbers:	ISTA-VIT-CS04
Study First Received:	September 13, 2005
Last Updated:	January 15, 2007
ClinicalTrials.gov Identifier:	NCT00198419
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypersensitivity
Drug Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009