Evaluation of Vitrase as an Adjuvant to Increase Absorption and Dispersion of Other Injected Anesthetics
Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00198549
Collaborator
(none)
40
1
5.9
6.7
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate Vitrase as an adjuvant to increase absorption and dispersion of other injected anesthetics
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase IV Post-Approval Evaluation of Vitrase as an Adjuvant to Increase the Absorption and Dispersion of Other Injected Anesthetics for Ophthalmic Surgical Procedures
Study Start Date
:
Sep 1, 2004
Actual Primary Completion Date
:
Jan 1, 2005
Actual Study Completion Date
:
Mar 1, 2005
Outcome Measures
Primary Outcome Measures
- To evaluate physician acceptance of efficacy of Vitrase as an adjuvant to increase absorption and dispersion of anesthetics used for ophthalmic surgical procedures []
Secondary Outcome Measures
- To determine physician usage of and satisfaction with Vitrase in the 6200 USP unit vial []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Scheduled for an ophthalmic surgical procedure
Exclusion Criteria:
- Known allergy to bee venom
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cincinnati Eye Institute | Cincinnati | Ohio | United States | 45242 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Lisa R Grillone, PhD, ISTA Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00198549
Other Study ID Numbers:
- ISTA-VIT-SA-MA02
First Posted:
Sep 20, 2005
Last Update Posted:
Mar 19, 2013
Last Verified:
Mar 1, 2013