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NCT00198484 Clinical Trial

Evaluation of Vitrase as a Spreading Agent

Pain Clinical Trial

Official title:
Evaluation of Vitrase (Hyaluronidase for Injection) Ovine, 200 USP Units/mL, as an Adjuvant to Increase the Absorption and Dispersion of Other Injected Drugs Prior to Ocular Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00198484
Other study ID # ISTA-VIT-SA-CS06
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated March 13, 2013
Start date October 2004
Est. completion date February 2005

Study information
Verified date March 2013
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Vitrase (hyaluronidase for injection) is effective as a spreading agent for other injected drugs prior to ocular surgery

Recruitment information / eligibility
Status Completed
Enrollment 108
Est. completion date February 2005
Est. primary completion date December 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Scheduled for an ophthalmic surgical procedure

Exclusion Criteria:

- Documented history of hypersensitivity to hyaluronidase or any other ingredient in Vitrase

- Known history of hypersensitivity reaction to bee or wasp venom

- Needing enhanced absorption and dispersion of dopamine, alpha agonist drugs, furosemide, the benzodiazepines, or phenytoin

- Inflammation or apparent clinical signs of infection in the area where Vitrase was to be injected

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

Locations
Country Name City State
United States Texan Eye Care PA Austin Texas
United States Cornea Consultants Boston Massachusetts
United States Cincinnati Eye Institute NKY Edgewood Kentucky
United States Advanced Eye Care, PC Fort Oglethorpe Georgia
United States Ophthalmology Service, Brooke Army Medical Center Ft. Sam Houston Texas
United States Ophthalmology Visual Science Galveston Texas
United States Donald E Beahm, MD Great Bend Kansas
United States Houston Eye Associates Houston Texas
United States Hunkeler Eye Institute Kansas City Missouri
United States E Randy Craven, MD Littleton Colorado
United States The Eye Care Group New Haven Connecticut
United States David Wirta, MD, Inc. Newport Beach California
United States Black Hills Regional Eye Institute Rapid City South Dakota
United States Ophthalmic Consultants of Long Island Rockville Centre New York
United States Richard A Lewis, MD Sacramento California
United States David G Shulman, MD San Antonio Texas
United States Central Texas Eye Center San Marcos Texas
United States David L Schwartz, MD Tulsa Oklahoma

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 Physician Satisfaction Survey Physician evaluation of effectiveness of Vitrase as an adjuvant and overall satisfaction, via questionnaire; 1-2 days No
Secondary Adverse Events occurrence, severity, relationship, duration, resolution, and seriousness of adverse events 1-2 days No
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