Evaluation of Vitrase as a Spreading Agent

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

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Vitrase

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • David Wirta, MD, Inc.
    • Sacramento, California, United States, 95815
      • Richard A Lewis, MD
  • Colorado
    • Littleton, Colorado, United States, 80120
      • E Randy Craven, MD
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • The Eye Care Group
  • Georgia
    • Fort Oglethorpe, Georgia, United States, 30742
      • Advanced Eye Care, PC
  • Kansas
    • Great Bend, Kansas, United States, 67530
      • Donald E Beahm, MD
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Cincinnati Eye Institute NKY
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Cornea Consultants
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Hunkeler Eye Institute
  • New York
    • Rockville Centre, New York, United States, 11570
      • Ophthalmic Consultants of Long Island
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • David L Schwartz, MD
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Texas
    • Austin, Texas, United States, 78705
      • Texan Eye Care PA
    • Ft. Sam Houston, Texas, United States, 78234
      • Ophthalmology Service, Brooke Army Medical Center
    • Galveston, Texas, United States, 77555
      • Ophthalmology Visual Science
    • Houston, Texas, United States, 77025
      • Houston Eye Associates
    • San Antonio, Texas, United States, 78209
      • David G Shulman, MD
    • San Marcos, Texas, United States, 78666
      • Central Texas Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Vitrase; Other Names: ovine hyaluronidase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Satisfaction Survey	Physician evaluation of effectiveness of Vitrase as an adjuvant and overall satisfaction, via questionnaire;	1-2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	occurrence, severity, relationship, duration, resolution, and seriousness of adverse events	1-2 days

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Lisa R Grillone, PhD, ISTA Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): February 1, 2005

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): March 14, 2013
• Last Update Submitted That Met QC Criteria: March 13, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Adjuvants, Anesthesia; Spreading Factor
• Other Study ID Numbers: ISTA-VIT-SA-CS06