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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00198549
First received: September 13, 2005
Last updated: March 15, 2013
Last verified: March 2013
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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:


Further study details as provided by Bausch & Lomb Incorporated:

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

Enrollment: 40
Study Start Date: September 2004
Study Completion Date: March 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for an ophthalmic surgical procedure

Exclusion Criteria:

  • Known allergy to bee venom
  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
Bausch & Lomb Incorporated
Investigators
Study Director: Lisa R Grillone, PhD ISTA Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00198549     History of Changes
Other Study ID Numbers: ISTA-VIT-SA-MA02
Study First Received: September 13, 2005
Last Updated: March 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Bausch & Lomb Incorporated:
Adjuvants, Anesthesia
hyaluronate lyase

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Anesthetics
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014