- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00198549
Evaluation of Vitrase as an Adjuvant to Increase Absorption and Dispersion of Other Injected Anesthetics
March 15, 2013 updated by: Bausch & Lomb Incorporated
Phase IV Post-Approval Evaluation of Vitrase as an Adjuvant to Increase the Absorption and Dispersion of Other Injected Anesthetics for Ophthalmic Surgical Procedures
The purpose of this study is to evaluate Vitrase as an adjuvant to increase absorption and dispersion of other injected anesthetics
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45242
- Cincinnati Eye Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Scheduled for an ophthalmic surgical procedure
Exclusion Criteria:
- Known allergy to bee venom
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
To determine physician usage of and satisfaction with Vitrase in the 6200 USP unit vial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lisa R Grillone, PhD, ISTA Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (Actual)
January 1, 2005
Study Completion (Actual)
March 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
March 19, 2013
Last Update Submitted That Met QC Criteria
March 15, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ISTA-VIT-SA-MA02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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