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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

January 15, 2007

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00198549 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase IV Post-Approval Evaluation of Vitrase as an Adjuvant to Increase the Absorption and Dispersion of Other Injected Anesthetics for Ophthalmic Surgical Procedures

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Vitrase (ovine hyaluronidase) Lyophilized

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Scheduled for an ophthalmic surgical procedure

Exclusion Criteria:

Known allergy to bee venom

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00198549

Responsible Party

Study ID Numbers ^ICMJE

ISTA-VIT-SA-MA02

Study Sponsor ^ICMJE

ISTA Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Lisa R Grillone, PhD

ISTA Pharmaceuticals, Inc.

Information Provided By

ISTA Pharmaceuticals

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP