Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
108 participants
INTERVENTIONAL
2004-10-31
2005-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vitrase
ovine hyaluronidase injection 150 USP Units in 1 mL solution. Single dose of Vitrase will be administered as an adjuvant prior to ophthalmologic surgery
Vitrase
Interventions
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Vitrase
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa R Grillone, PhD
Role: STUDY_DIRECTOR
ISTA Pharmaceuticals, Inc.
Locations
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David Wirta, MD, Inc.
Newport Beach, California, United States
Richard A Lewis, MD
Sacramento, California, United States
E Randy Craven, MD
Littleton, Colorado, United States
The Eye Care Group
New Haven, Connecticut, United States
Advanced Eye Care, PC
Fort Oglethorpe, Georgia, United States
Donald E Beahm, MD
Great Bend, Kansas, United States
Cincinnati Eye Institute NKY
Edgewood, Kentucky, United States
Cornea Consultants
Boston, Massachusetts, United States
Hunkeler Eye Institute
Kansas City, Missouri, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States
David L Schwartz, MD
Tulsa, Oklahoma, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Texan Eye Care PA
Austin, Texas, United States
Ophthalmology Service, Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Ophthalmology Visual Science
Galveston, Texas, United States
Houston Eye Associates
Houston, Texas, United States
David G Shulman, MD
San Antonio, Texas, United States
Central Texas Eye Center
San Marcos, Texas, United States
Countries
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Other Identifiers
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ISTA-VIT-SA-CS06
Identifier Type: -
Identifier Source: org_study_id
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