Evaluation of Vitrase as a Spreading Agent

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Vitrase

• Registration Number: NCT00198484
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2004-12
• Study Completion: 2005-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitrase	Vitrase	ovine hyaluronidase injection 150 USP Units in 1 mL solution. Single dose of Vitrase will be administered as an adjuvant prior to ophthalmologic surgery

Primary Outcome Measures

Name	Time	Method
Physician Satisfaction Survey	1-2 days	Physician evaluation of effectiveness of Vitrase as an adjuvant and overall satisfaction, via questionnaire;

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1-2 days	occurrence, severity, relationship, duration, resolution, and seriousness of adverse events

Trial Locations

Locations (18)

Donald E Beahm, MD; 🇺🇸 Great Bend, Kansas, United States

Ophthalmic Consultants of Long Island; 🇺🇸 Rockville Centre, New York, United States

Cornea Consultants; 🇺🇸 Boston, Massachusetts, United States

Ophthalmology Visual Science; 🇺🇸 Galveston, Texas, United States

Central Texas Eye Center; 🇺🇸 San Marcos, Texas, United States

Cincinnati Eye Institute NKY; 🇺🇸 Edgewood, Kentucky, United States

David Wirta, MD, Inc.; 🇺🇸 Newport Beach, California, United States

E Randy Craven, MD; 🇺🇸 Littleton, Colorado, United States

Richard A Lewis, MD; 🇺🇸 Sacramento, California, United States

The Eye Care Group; 🇺🇸 New Haven, Connecticut, United States

Hunkeler Eye Institute; 🇺🇸 Kansas City, Missouri, United States

Advanced Eye Care, PC; 🇺🇸 Fort Oglethorpe, Georgia, United States

David L Schwartz, MD; 🇺🇸 Tulsa, Oklahoma, United States

Black Hills Regional Eye Institute; 🇺🇸 Rapid City, South Dakota, United States

Texan Eye Care PA; 🇺🇸 Austin, Texas, United States

Ophthalmology Service, Brooke Army Medical Center; 🇺🇸 Ft. Sam Houston, Texas, United States

David G Shulman, MD; 🇺🇸 San Antonio, Texas, United States

Houston Eye Associates; 🇺🇸 Houston, Texas, United States