- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00198419
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
March 13, 2013 updated by: Bausch & Lomb Incorporated
Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase) Open Label, Normal Volunteer Study
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Davis, California, United States, 95616
- Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypersensitivity
Time Frame: 1-2 days
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hypersensitivity to Vitrase following a single intradermal injection of 3 USP Units Vitrase
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1-2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lisa R Grillone, PhD, ISTA Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Primary Completion (Actual)
March 1, 2004
Study Completion (Actual)
March 1, 2004
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
March 14, 2013
Last Update Submitted That Met QC Criteria
March 13, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISTA-VIT-CS04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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