PainPhase 3NCT00198484
Evaluation of Vitrase as a Spreading Agent
A Phase 3 study testing Vitrase in people with Pain, run by Bausch & Lomb Incorporated at 18 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Vitrase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 18 sitesUnited States
- Study dates
- Oct 2004to Feb 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for an ophthalmic surgical procedure
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Texan Eye Care PA
Austin, Texas, 78705
Cornea Consultants
Boston, Massachusetts, 02114
Cincinnati Eye Institute NKY
Edgewood, Kentucky, 41017
Advanced Eye Care, PC
Fort Oglethorpe, Georgia, 30742
Ophthalmology Service, Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Ophthalmology Visual Science
Galveston, Texas, 77555
Donald E Beahm, MD
Great Bend, Kansas, 67530
Houston Eye Associates
Houston, Texas, 77025
Hunkeler Eye Institute
Kansas City, Missouri, 64111
E Randy Craven, MD
Littleton, Colorado, 80120
The Eye Care Group
New Haven, Connecticut, 06510
David Wirta, MD, Inc.
Newport Beach, California, 92663
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570
Richard A Lewis, MD
Sacramento, California, 95815
David G Shulman, MD
San Antonio, Texas, 78209
Central Texas Eye Center
San Marcos, Texas, 78666
David L Schwartz, MD
Tulsa, Oklahoma, 74104
About this study
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
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
- Conditions
- Pain
- Being tested
- Vitrase
- Keywords
- Adjuvants, Anesthesia, Spreading Factor
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitraseDrug
Also called ovine hyaluronidase
| Study group | Role | What they receive |
|---|---|---|
| Vitrase | Experimental | ovine hyaluronidase injection 150 USP Units in 1 mL solution. Single dose of Vitrase will be administered as an adjuvant prior to ophthalmologic surgery Receives: Drug: Vitrase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Satisfaction Survey
Physician evaluation of effectiveness of Vitrase as an adjuvant and overall satisfaction, via questionnaire;
Measured: 1-2 days
Secondary outcomes (1)
Adverse Events
occurrence, severity, relationship, duration, resolution, and seriousness of adverse events
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2004
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa R Grillone, PhD, Study director, ISTA Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198484
- Sponsor's protocol ID
- ISTA-VIT-SA-CS06
- Status last verified
- Mar 2013
- First submitted
- 13 Sep 2005
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00198484
- Acronym / sponsor ID
- ISTA-VIT-SA-CS06
- Conditions
- Pain
- Keywords
- Adjuvants, Anesthesia, Spreading Factor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitrase | Experimental | Drug: Vitraseovine hyaluronidase injection 150 USP Units in 1 mL solution. Single dose of Vitrase will be administered as an adjuvant prior to ophthalmologic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for an ophthalmic surgical procedure
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitraseAlso: ovine hyaluronidase | Drug | Vitrase |
Primary outcome
Physician Satisfaction Survey
Time frame: 1-2 days
Physician evaluation of effectiveness of Vitrase as an adjuvant and overall satisfaction, via questionnaire;
1 secondary outcome
Adverse Events
Time frame: 1-2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa R Grillone, PhD study director
ISTA Pharmaceuticals, Inc.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitrase in people with Pain, run by Bausch & Lomb Incorporated at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Satisfaction Survey (time frame: 1-2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2013.