Evaluation of Vitrase as a Spreading Agent
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ClinicalTrials.gov Identifier: NCT00198484 |
Recruitment Status :
Completed
First Posted : September 20, 2005
Last Update Posted : March 14, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain | Drug: Vitrase | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 108 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | October 2004 |
Actual Primary Completion Date : | December 2004 |
Actual Study Completion Date : | February 2005 |

Arm | Intervention/treatment |
---|---|
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
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Drug: Vitrase
Other Name: ovine hyaluronidase |
- Physician Satisfaction Survey [ Time Frame: 1-2 days ]Physician evaluation of effectiveness of Vitrase as an adjuvant and overall satisfaction, via questionnaire;
- Adverse Events [ Time Frame: 1-2 days ]occurrence, severity, relationship, duration, resolution, and seriousness of adverse events

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198484

Study Director: | Lisa R Grillone, PhD | ISTA Pharmaceuticals, Inc. |
Responsible Party: | Bausch & Lomb Incorporated |
ClinicalTrials.gov Identifier: | NCT00198484 |
Other Study ID Numbers: |
ISTA-VIT-SA-CS06 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | March 14, 2013 |
Last Verified: | March 2013 |
Adjuvants, Anesthesia Spreading Factor |