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Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00198458
Collaborator
(none)
65
Enrollment
1
Location
1
Arm
2
Duration (Months)
31.9
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Jul 1, 2004
Actual Primary Completion Date :
Jul 1, 2004
Actual Study Completion Date :
Sep 1, 2004

Arms and Interventions

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 Names:
  • ovine hyaluronidase

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hypersensitivity [1-2 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Solano Clinical Research (A Division of Dow Pharmaceutical Sciences) Davis California United States 95616

    Sponsors and Collaborators

    • Bausch & Lomb Incorporated

    Investigators

    • Study Director: Lisa R Grillone, PhD, ISTA Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT00198458
    Other Study ID Numbers:
    • ISTA-VIT-CS05
    First Posted:
    Sep 20, 2005
    Last Update Posted:
    Mar 18, 2013
    Last Verified:
    Mar 1, 2013
    Additional relevant MeSH terms:
    Hypersensitivity
    Drug Hypersensitivity

    Study Results

    No Results Posted as of Mar 18, 2013