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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.
 
ClinicalTrials.gov Identifier: NCT00198419
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 14, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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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 10% hypersensitivity response was considered acceptable.

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

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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Vitrase
a single intradermal dose of 3 USP Units of Vitrase (ovine hyaluronidase) at one site and the same volume of saline at a distant site for comparative control
 Drug: Vitrase
Other Name: ovine hyaluronidase


Outcome Measures
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Primary Outcome Measures :
  1. Hypersensitivity [ Time Frame: 1-2 days ]
    hypersensitivity to Vitrase following a single intradermal injection of 3 USP Units Vitrase


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00198419


Locations
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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
Investigators
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Study Director: Lisa R Grillone, PhD ISTA Pharmaceuticals, Inc.
More Information
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00198419    
Other Study ID Numbers: ISTA-VIT-CS04
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders