NCT00198458

Brief 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 a 10% hypersensitivity response was considered acceptable.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

Enrollment Period

Same day

First QC Date

September 13, 2005

Last Update Submit

March 14, 2013

Conditions

Drug Hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • Hypersensitivity

    Incidence of hypersensitivity to Vitrase following a single intradermal injection of 4.5 USP units Vitrase.

    1-2 days

Study Arms (1)

Vitrase

EXPERIMENTAL

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.

Drug: Vitrase

Interventions

VitraseDRUG
Also known as: ovine hyaluronidase
Vitrase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Agreed to avoid disallowed meds

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Drug Hypersensitivity

Interventions

Chondroitinases and Chondroitin Lyases

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

SulfatasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesPolysaccharide-LyasesCarbon-Oxygen LyasesLyases

Study Officials

  • Lisa R Grillone, PhD

    ISTA Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

July 1, 2004

Primary Completion

July 1, 2004

Study Completion

September 1, 2004

Last Updated

March 18, 2013

Record last verified: 2013-03

Locations

US(1)