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

This study has been completed.

First Received on September 13, 2005. Last Updated on 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:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

Drug Information available for: Hyaluronidase

U.S. FDA Resources

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

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

Keywords provided by ISTA Pharmaceuticals:

Adjuvants, Anesthesia
hyaluronate lyase

Additional relevant MeSH terms:

Adjuvants, Immunologic
Adjuvants, Anesthesia
Anesthetics
Immunologic Factors
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 12, 2012