Evaluation of Vitrase as a Spreading Agent

NCT ID: NCT00198484

Last Updated: 2013-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-02-28

Brief Summary

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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

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Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Vitrase

Intervention Type DRUG

Interventions

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Vitrase

Intervention Type DRUG

Other Intervention Names

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ovine hyaluronidase

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa R Grillone, PhD

Role: STUDY_DIRECTOR

ISTA Pharmaceuticals, Inc.

Locations

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David Wirta, MD, Inc.

Newport Beach, California, United States

Site Status

Richard A Lewis, MD

Sacramento, California, United States

Site Status

E Randy Craven, MD

Littleton, Colorado, United States

Site Status

The Eye Care Group

New Haven, Connecticut, United States

Site Status

Advanced Eye Care, PC

Fort Oglethorpe, Georgia, United States

Site Status

Donald E Beahm, MD

Great Bend, Kansas, United States

Site Status

Cincinnati Eye Institute NKY

Edgewood, Kentucky, United States

Site Status

Cornea Consultants

Boston, Massachusetts, United States

Site Status

Hunkeler Eye Institute

Kansas City, Missouri, United States

Site Status

Ophthalmic Consultants of Long Island

Rockville Centre, New York, United States

Site Status

David L Schwartz, MD

Tulsa, Oklahoma, United States

Site Status

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Site Status

Texan Eye Care PA

Austin, Texas, United States

Site Status

Ophthalmology Service, Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status

Ophthalmology Visual Science

Galveston, Texas, United States

Site Status

Houston Eye Associates

Houston, Texas, United States

Site Status

David G Shulman, MD

San Antonio, Texas, United States

Site Status

Central Texas Eye Center

San Marcos, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ISTA-VIT-SA-CS06

Identifier Type: -

Identifier Source: org_study_id

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