Clinical trial NCT00198484: Evaluation of Vitrase as a Spreading Agent
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Adjuvants, Anesthesia
Spreading Factor
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Physician Satisfaction Survey
timeFrame: 1-2 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 1-2 days
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: David Wirta, MD, Inc.
state: California
city: Sacramento
country: United States
facility: Richard A Lewis, MD
state: California
city: Littleton
country: United States
facility: E Randy Craven, MD
state: Colorado
city: New Haven
country: United States
facility: The Eye Care Group
state: Connecticut
city: Fort Oglethorpe
country: United States
facility: Advanced Eye Care, PC
state: Georgia
city: Great Bend
country: United States
facility: Donald E Beahm, MD
state: Kansas
city: Edgewood
country: United States
facility: Cincinnati Eye Institute NKY
state: Kentucky
city: Boston
country: United States
facility: Cornea Consultants
state: Massachusetts
city: Kansas City
country: United States
facility: Hunkeler Eye Institute
state: Missouri
city: Rockville Centre
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Tulsa
country: United States
facility: David L Schwartz, MD
state: Oklahoma
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Austin
country: United States
facility: Texan Eye Care PA
state: Texas
city: Ft. Sam Houston
country: United States
facility: Ophthalmology Service, Brooke Army Medical Center
state: Texas
city: Galveston
country: United States
facility: Ophthalmology Visual Science
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: San Antonio
country: United States
facility: David G Shulman, MD
state: Texas
city: San Marcos
country: United States
facility: Central Texas Eye Center
state: Texas
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Lisa R Grillone, PhD
role: STUDY_DIRECTOR
References: