Evaluation of Vitrase as a Spreading Agent
This study has been completed.
Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00198484
First received: September 13, 2005
Last updated: March 13, 2013
Last verified: March 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Vitrase |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bausch & Lomb Incorporated:
Primary Outcome Measures:
- Physician Satisfaction Survey [ Time Frame: 1-2 days ] [ Designated as safety issue: No ]Physician evaluation of effectiveness of Vitrase as an adjuvant and overall satisfaction, via questionnaire;
Secondary Outcome Measures:
- Adverse Events [ Time Frame: 1-2 days ] [ Designated as safety issue: No ]occurrence, severity, relationship, duration, resolution, and seriousness of adverse events
| Enrollment: | 108 |
| Study Start Date: | October 2004 |
| Study Completion Date: | February 2005 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
Drug: Vitrase
Other Name: ovine hyaluronidase
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198484
Locations
| United States, California | |
| David Wirta, MD, Inc. | |
| Newport Beach, California, United States, 92663 | |
| Richard A Lewis, MD | |
| Sacramento, California, United States, 95815 | |
| United States, Colorado | |
| E Randy Craven, MD | |
| Littleton, Colorado, United States, 80120 | |
| United States, Connecticut | |
| The Eye Care Group | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Georgia | |
| Advanced Eye Care, PC | |
| Fort Oglethorpe, Georgia, United States, 30742 | |
| United States, Kansas | |
| Donald E Beahm, MD | |
| Great Bend, Kansas, United States, 67530 | |
| United States, Kentucky | |
| Cincinnati Eye Institute NKY | |
| Edgewood, Kentucky, United States, 41017 | |
| United States, Massachusetts | |
| Cornea Consultants | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Missouri | |
| Hunkeler Eye Institute | |
| Kansas City, Missouri, United States, 64111 | |
| United States, New York | |
| Ophthalmic Consultants of Long Island | |
| Rockville Centre, New York, United States, 11570 | |
| United States, Oklahoma | |
| David L Schwartz, MD | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, South Dakota | |
| Black Hills Regional Eye Institute | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Texas | |
| Texan Eye Care PA | |
| Austin, Texas, United States, 78705 | |
| Ophthalmology Service, Brooke Army Medical Center | |
| Ft. Sam Houston, Texas, United States, 78234 | |
| Ophthalmology Visual Science | |
| Galveston, Texas, United States, 77555 | |
| Houston Eye Associates | |
| Houston, Texas, United States, 77025 | |
| David G Shulman, MD | |
| San Antonio, Texas, United States, 78209 | |
| Central Texas Eye Center | |
| San Marcos, Texas, United States, 78666 | |
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
| Study Director: | Lisa R Grillone, PhD | ISTA Pharmaceuticals, Inc. |
More Information
No publications provided
| Responsible Party: | Bausch & Lomb Incorporated |
| ClinicalTrials.gov Identifier: | NCT00198484 History of Changes |
| Other Study ID Numbers: | ISTA-VIT-SA-CS06 |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bausch & Lomb Incorporated:
|
Adjuvants, Anesthesia Spreading Factor |
Additional relevant MeSH terms:
|
Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013