Drug HypersensitivityPhase 1NCT00198458
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
A Phase 1 study testing Vitrase in people with Drug Hypersensitivity, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to a 10% hypersensitivity response was considered acceptable. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Hypersensitivity
- What is being tested?
- Vitrase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Sep 2004
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agreed to avoid disallowed meds
Who cannot join
- Known hypersensitivity to hyaluronidase and/or bee sting
- Previous known exposure to ovine hyaluronidase or bovine hyaluronidase
- Atopic individuals assessed by medical history
- Topical/inhaled/systemic corticosteroids within 30 days
- Concurrent use of antihistamines or anti-inflammatory during study
- Active or chronic disease likely to affect immune function
- History of alcohol/drug abuse within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)
Davis, California, 95616
About this study
Official title: Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study
The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to a 10% hypersensitivity response was considered acceptable.
- Conditions
- Drug Hypersensitivity
- Being tested
- Vitrase
- Medical subject headings
- Drug Hypersensitivity
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 | A single intradermal dose of 4.5 USP units of Vitrase at one site and the same volume of saline at a distant site for comparative control. Receives: Drug: Vitrase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypersensitivity
Incidence of hypersensitivity to Vitrase following a single intradermal injection of 4.5 USP units Vitrase.
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 startJul 2004
- Primary completionJul 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug HypersensitivityStudies 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants
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
- NCT00198458
- Sponsor's protocol ID
- ISTA-VIT-CS05
- Status last verified
- Mar 2013
- First submitted
- 13 Sep 2005
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study
- ClinicalTrials.gov ID
- NCT00198458
- Acronym / sponsor ID
- ISTA-VIT-CS05
- Conditions
- Drug Hypersensitivity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Jul 2004 (actual)
- Study completion
- Sep 2004 (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 objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to a 10% hypersensitivity response was considered acceptable.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitrase | Experimental | Drug: VitraseA single intradermal dose of 4.5 USP units of Vitrase at one site and the same volume of saline at a distant site for comparative control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Agreed to avoid disallowed meds
Key exclusion criteria (7 listed)
- Known hypersensitivity to hyaluronidase and/or bee sting
- Previous known exposure to ovine hyaluronidase or bovine hyaluronidase
- Atopic individuals assessed by medical history
- Topical/inhaled/systemic corticosteroids within 30 days
- Concurrent use of antihistamines or anti-inflammatory during study
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
Hypersensitivity
Time frame: 1-2 days
Incidence of hypersensitivity to Vitrase following a single intradermal injection of 4.5 USP units Vitrase.
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 18 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitrase in people with Drug Hypersensitivity, run by Bausch & Lomb Incorporated at 1 site 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 7 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 18 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 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Hypersensitivity (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 18 Mar 2013.