Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
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ClinicalTrials.gov Identifier: NCT00198419 |
Recruitment Status :
Completed
First Posted : September 20, 2005
Last Update Posted : March 14, 2013
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Condition or disease | Intervention/treatment | Phase |
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Drug Hypersensitivity | Drug: Vitrase | Phase 1 |
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 |

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
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Drug: Vitrase
Other Name: ovine hyaluronidase |
- Hypersensitivity [ Time Frame: 1-2 days ]hypersensitivity to Vitrase following a single intradermal injection of 3 USP Units Vitrase

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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:
- 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

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
United States, California | |
Solano Clinical Research (A Division of Dow Pharmaceutical Sciences) | |
Davis, California, United States, 95616 |
Study Director: | Lisa R Grillone, PhD | ISTA Pharmaceuticals, Inc. |
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 |
Hypersensitivity Drug Hypersensitivity Immune System Diseases Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders |