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Evaluation of Vitrase as a Spreading Agent

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00198484
Collaborator
(none)
108
Enrollment
18
Locations
1
Arm
4
Duration (Months)
6
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Oct 1, 2004
Actual Primary Completion Date :
Dec 1, 2004
Actual Study Completion Date :
Feb 1, 2005

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Physician Satisfaction Survey [1-2 days]

      Physician evaluation of effectiveness of Vitrase as an adjuvant and overall satisfaction, via questionnaire;

    Secondary Outcome Measures

    1. Adverse Events [1-2 days]

      occurrence, severity, relationship, duration, resolution, and seriousness of adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

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

    Sponsors and Collaborators

    • Bausch & Lomb Incorporated

    Investigators

    • Study Director: Lisa R Grillone, PhD, ISTA Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT00198484
    Other Study ID Numbers:
    • ISTA-VIT-SA-CS06
    First Posted:
    Sep 20, 2005
    Last Update Posted:
    Mar 14, 2013
    Last Verified:
    Mar 1, 2013
    Keywords provided by Bausch & Lomb Incorporated
    Adjuvants, Anesthesia
    Spreading Factor

    Study Results

    No Results Posted as of Mar 14, 2013