Evaluation of Vitrase as a Spreading Agent

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

Completed

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

David Wirta, MD, Inc., Newport Beach, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitrase

Drug

Other names: ovine hyaluronidase

Primary outcomes

Physician Satisfaction Survey

Time frame: 1-2 days

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

Secondary outcomes

Adverse Events

Time frame: 1-2 days

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

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study 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

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2005
First posted: Sep 20, 2005
Registry last updated: Mar 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed