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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
History of Changes
  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:

U.S. FDA Resources

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, 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 May 16, 2013