Evaluation of Vitrase as a Spreading Agent

Phase 3CompletedNCT00198484

Bausch & Lomb Incorporated108 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

108

Conditions

Pain

Interventions

VitraseDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

David Wirta, MD, Inc.

Newport Beach, California, United States

Richard A Lewis, MD

Sacramento, California, United States

Outcomes

Primary Outcomes

Physician Satisfaction Survey

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

Time frame: 1-2 days

Secondary Outcomes

Adverse Events

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

Time frame: 1-2 days

Data from ClinicalTrials.gov

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