Evaluation of Vitrase as an Adjuvant to Increase Absorption and Dispersion of Other Injected Anesthetics

This study has been completed.

First Received: September 13, 2005 Last Updated: January 15, 2007 History of Changes

Sponsor:	ISTA Pharmaceuticals
Information provided by:	ISTA Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00198549

Purpose

The purpose of this study is to evaluate Vitrase as an adjuvant to increase absorption and dispersion of other injected anesthetics

Condition	Intervention	Phase
Pain	Drug: Vitrase (ovine hyaluronidase) Lyophilized	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Phase IV Post-Approval Evaluation of Vitrase as an Adjuvant to Increase the Absorption and Dispersion of Other Injected Anesthetics for Ophthalmic Surgical Procedures

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Surgery

Drug Information available for: Hyaluronidase

Further study details as provided by ISTA Pharmaceuticals:

Primary Outcome Measures:

To evaluate physician acceptance of efficacy of Vitrase as an adjuvant to increase absorption and dispersion of anesthetics used for ophthalmic surgical procedures

Secondary Outcome Measures:

To determine physician usage of and satisfaction with Vitrase in the 6200 USP unit vial

Estimated Enrollment:	40
Study Start Date:	September 2004
Estimated Study Completion Date:	January 2005

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198549

Locations

United States, Ohio
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242

Sponsors and Collaborators

ISTA Pharmaceuticals

Investigators

Study Director:

Lisa R Grillone, PhD

ISTA Pharmaceuticals, Inc.

More Information

No publications provided

Study ID Numbers:	ISTA-VIT-SA-MA02
Study First Received:	September 13, 2005
Last Updated:	January 15, 2007
ClinicalTrials.gov Identifier:	NCT00198549 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by ISTA Pharmaceuticals:

Adjuvants, Anesthesia
hyaluronate lyase

Additional relevant MeSH terms:

Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs
Adjuvants, Immunologic

Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009