Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

ClinicalTrials.gov ID: NCT00198458

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Official title

Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT00198458
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Bausch & Lomb Incorporated; Industry
Enrollment: 65 participants

Conditions and interventions

Conditions

Drug Hypersensitivity

Interventions

Vitrase Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 2004 (Type not available)
Primary completion: Jul 2004 (Actual)
Completion: Sep 2004 (Actual)
Last update posted: Mar 18, 2013

2004

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)	Davis	California	95616	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00198458, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 18, 2013 · Synced Nov 12, 2026