Evaluation of Vitrase as a Spreading Agent

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00198484

Enrollment

108

Registered

2005-09-20

Start date

2004-10-31

Completion date

2005-02-28

Last updated

2013-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Adjuvants, Anesthesia, Spreading Factor

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

Interventions

DRUGVitrase

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Physician Satisfaction Survey	1-2 days	Physician evaluation of effectiveness of Vitrase as an adjuvant and overall satisfaction, via questionnaire;

Secondary

Measure	Time frame	Description
Adverse Events	1-2 days	occurrence, severity, relationship, duration, resolution, and seriousness of adverse events

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026