Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

This study has been completed.

First Received on September 13, 2005. Last Updated on January 15, 2007 History of Changes

Sponsor:	ISTA Pharmaceuticals
Information provided by:	ISTA Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00198458

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 a 10% hypersensitivity response was considered acceptable.

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

Study Type:	Observational
Study Design:	Observational Model: Defined Population Time Perspective: Cross-Sectional Time Perspective: Prospective
Official Title:	Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study

Resource links provided by NLM:

MedlinePlus related topics: Allergy Drug Reactions

Drug Information available for: Hyaluronidase

U.S. FDA Resources

Further study details as provided by ISTA Pharmaceuticals:

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

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198458

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00198458 History of Changes
Other Study ID Numbers:	ISTA-VIT-CS05
Study First Received:	September 13, 2005
Last Updated:	January 15, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Drug Hypersensitivity
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 12, 2012