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NCT00198549 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00198549
Other study ID # ISTA-VIT-SA-MA02
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated March 15, 2013
Start date September 2004
Est. completion date March 2005

Study information
Verified date March 2013
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 2005
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Scheduled for an ophthalmic surgical procedure

Exclusion Criteria:

- Known allergy to bee venom

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vitrase (ovine hyaluronidase) Lyophilized

Locations
Country Name City State
United States Cincinnati Eye Institute Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate physician acceptance of efficacy of Vitrase as an adjuvant to increase absorption and dispersion of anesthetics used for ophthalmic surgical procedures
Secondary To determine physician usage of and satisfaction with Vitrase in the 6200 USP unit vial
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