Evaluation of Vitrase as a Spreading Agent

NCT00198484 | Completed Phase 3

• 1 other identifier: ISTA-VIT-SA-CS06
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 18

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

Conditions

Pain

Keywords

Adjuvants, Anesthesia; Spreading Factor

Outcome Measures

Primary Outcomes (1)

• Physician Satisfaction Survey

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

  1-2 days

Secondary Outcomes (1)

• Adverse Events

  1-2 days

Study Arms (1)

Vitrase

EXPERIMENTAL

ovine hyaluronidase injection 150 USP Units in 1 mL solution. Single dose of Vitrase will be administered as an adjuvant prior to ophthalmologic surgery

Drug: Vitrase

Interventions

Vitrase DRUG

Also known as: ovine hyaluronidase

Vitrase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for an ophthalmic surgical procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (18)

David Wirta, MD, Inc.

Newport Beach, California, 92663, United States

Location

Richard A Lewis, MD

Sacramento, California, 95815, United States

Location

E Randy Craven, MD

Littleton, Colorado, 80120, United States

Location

The Eye Care Group

New Haven, Connecticut, 06510, United States

Location

Advanced Eye Care, PC

Fort Oglethorpe, Georgia, 30742, United States

Location

Donald E Beahm, MD

Great Bend, Kansas, 67530, United States

Location

Cincinnati Eye Institute NKY

Edgewood, Kentucky, 41017, United States

Location

Cornea Consultants

Boston, Massachusetts, 02114, United States

Location

Hunkeler Eye Institute

Kansas City, Missouri, 64111, United States

Location

Ophthalmic Consultants of Long Island

Rockville Centre, New York, 11570, United States

Location

David L Schwartz, MD

Tulsa, Oklahoma, 74104, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Texan Eye Care PA

Austin, Texas, 78705, United States

Location

Ophthalmology Service, Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Ophthalmology Visual Science

Galveston, Texas, 77555, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

David G Shulman, MD

San Antonio, Texas, 78209, United States

Location

Central Texas Eye Center

San Marcos, Texas, 78666, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Chondroitinases and Chondroitin Lyases

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfatases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases

Study Officials

• Lisa R Grillone, PhD

  ISTA Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: October 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: February 1, 2005
• Last Updated: March 14, 2013

Record last verified: 2013-03

Locations

US (18)