Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

March 14, 2013 updated by: Bausch & Lomb Incorporated

Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) 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 a 10% hypersensitivity response was considered acceptable.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment

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

    • California
      • Davis, California, United States, 95616
        • Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)

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

No

Genders Eligible for Study

All

Description

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

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

  • 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 4.5 USP units of Vitrase at one site and the same volume of saline at a distant site for comparative control.
Other Names:
  • ovine hyaluronidase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypersensitivity
Time Frame: 1-2 days
Incidence of hypersensitivity to Vitrase following a single intradermal injection of 4.5 USP units Vitrase.
1-2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

July 1, 2004

Primary Completion (Actual)

July 1, 2004

Study Completion (Actual)

September 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 18, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

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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