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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:
ClinicalTrials.gov Identifier:
NCT00198549
First Posted: September 20, 2005
Last Update Posted: March 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  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: Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for an ophthalmic surgical procedure

Exclusion Criteria:

  • Known allergy to bee venom
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00198549     History of Changes
Other Study ID Numbers: ISTA-VIT-SA-MA02
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: March 19, 2013
Last Verified: March 2013

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

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs