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

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.
 
ClinicalTrials.gov Identifier: NCT00198549
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 19, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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

Condition or disease Intervention/treatment Phase
Pain Drug: Vitrase (ovine hyaluronidase) Lyophilized Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
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
Study Start Date : September 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : March 2005

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Primary Outcome Measures :
  1. 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 :
  1. To determine physician usage of and satisfaction with Vitrase in the 6200 USP unit vial


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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United States, Ohio
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Lisa R Grillone, PhD ISTA Pharmaceuticals, Inc.
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00198549    
Other Study ID Numbers: ISTA-VIT-SA-MA02
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013
Keywords provided by Bausch & Lomb Incorporated:
Adjuvants, Anesthesia
hyaluronate lyase