Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

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.

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Key information

Conditions

Drug Hypersensitivity Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)

Davis, California, 95616, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitrase

Drug

Other names: ovine hyaluronidase

Primary outcomes

Hypersensitivity

Time frame: 1-2 days

Incidence of hypersensitivity to Vitrase following a single intradermal injection of 4.5 USP units Vitrase.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2004
First posted: Sep 20, 2005
Registry last updated: Mar 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed