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Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00198458
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 18, 2013
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief 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.

Condition or disease Intervention/treatment Phase
Drug Hypersensitivity Drug: Vitrase Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study
Study Start Date : July 2004
Actual Primary Completion Date : July 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Drug: Vitrase
Other Name: ovine hyaluronidase

Primary Outcome Measures :
  1. Hypersensitivity [ Time Frame: 1-2 days ]
    Incidence of hypersensitivity to Vitrase following a single intradermal injection of 4.5 USP units Vitrase.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00198458

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United States, California
Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)
Davis, California, United States, 95616
Sponsors and Collaborators
Bausch & Lomb Incorporated
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Study Director: Lisa R Grillone, PhD ISTA Pharmaceuticals, Inc.
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Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00198458    
Other Study ID Numbers: ISTA-VIT-CS05
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders