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NCT00198419 · ClinicalTrials.gov registry record · Phase 1

Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

A Phase 1 study, sponsored by Bausch & Lomb Incorporated.

Completed
Registry status
Phase 1
Development phase
65
Enrollment target

NCT00198419 is a Phase 1 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 65 participants.

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The verdict

NCT00198419, a Phase 1 study, has completed, sponsored by Bausch & Lomb Incorporated.

COMPLETED
Registry status
Phase 1
Development phase
65 participants
Enrollment target

Study 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 10% hypersensitivity response was considered acceptable.

Interventions

  • DRUG Vitrase

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2004-03
Est. Completion 2004-03
Phase Phase 1

Sponsor

Bausch & Lomb Incorporated

174 total trials

What the Registry Record Tells You About NCT00198419

The ClinicalTrials.gov registry entry for NCT00198419 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch & Lomb Incorporated, which has 174 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Vitrase is the first listed.

NCT00198419 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00198419 about?

NCT00198419 is a clinical study titled "Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)". 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.

What is the current status of trial NCT00198419?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2004-03. Estimated completion is 2004-03.

What interventions are being tested in trial NCT00198419?

The interventions under investigation include: Vitrase (DRUG).

Who is sponsoring clinical trial NCT00198419?

This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.