Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Vitrase as a Spreading Agent

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: NCT00198484
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 14, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Pain Drug: Vitrase Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: ovine hyaluronidase


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Physician Satisfaction Survey [ Time Frame: 1-2 days ]
    Physician evaluation of effectiveness of Vitrase as an adjuvant and overall satisfaction, via questionnaire;


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 1-2 days ]
    occurrence, severity, relationship, duration, resolution, and seriousness of adverse events


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00198484


Locations
Show Show 18 study locations
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Layout table for investigator information
Study Director: Lisa R Grillone, PhD ISTA Pharmaceuticals, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00198484    
Other Study ID Numbers: ISTA-VIT-SA-CS06
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013
Keywords provided by Bausch & Lomb Incorporated:
Adjuvants, Anesthesia
Spreading Factor