Histamine Responsive Allergy PatientsPhase 4NCT01128556
The Evaluation of Bepreve on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing
A Phase 4 study testing Bepreve and Refresh Tears in people with Histamine Responsive Allergy Patients, run by North Texas Institute for Clinical Trials at 1 site in United States.
Trial summary
To evaluate the effect of BEPREVE compared to a REFRESH Tears Lubricant eye drop on the measurement of the wheal and flare from histamine skin prick testing. This is an open label, two-week, post-marketing study conducted on histamine responsive patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Histamine Responsive Allergy Patients
- What is being tested?
- Bepreve and Refresh Tears
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2010
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects, 18 to 65 years of age
- Patients must demonstrate a positive reaction to a Histamine skin-prick test. Manifested by a histamine-induced wheal of >3mm in diameter over the normal saline control after 15 minutes of elapsed time
Who cannot join
- Significant signs and symptoms of currently active allergic disease (SAR, perennial allergic rhinitis, episodic allergic rhinitis)
- Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to visit 1
- Subjects who have dermatographism or other skin conditions which might interfere with the interpretation of the skin test results
- Subjects who are receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy
- Known hypersensitivity to the investigational product or to drugs with similar chemical properties
- Pregnancy and/or breast feeding
- Use of antihistamines, NSAIDS, steroids, or other drugs which may affect the skin-response
- Use of any medications or agents that are not specified above that may confound the interpretation of the results
Trial locations and contacts
1 site in 1 country.
United States1 site
North Texas Institute for Clinical Trials
Fort Worth, Texas, 76132
About this study
Official title: The Evaluation of the Effect of Bepreve, a Topical Ocular Antihistamine, on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing
To evaluate the effect of BEPREVE compared to a REFRESH Tears Lubricant eye drop on the measurement of the wheal and flare from histamine skin prick testing. This is an open label, two-week, post-marketing study conducted on histamine responsive patients.
- Conditions
- Histamine Responsive Allergy Patients
- Being tested
- Bepreve, Refresh Tears
- Keywords
- allergic conjunctivitis, histamine skin testing
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BepreveDrug
Also called bepotastine besilate
Bepreve (bepotastine besilate ophthalmic solution 1.5%) one drop in each eye twice daily
Refresh TearsDrug
Refresh Tears one drop to each eye twice daily for 7 days after the conclusion of Bepreve treatment
| Study group | Role | What they receive |
|---|---|---|
| Bepreve | Experimental | topical ocular treatment as indicated Receives: Drug: Bepreve; Drug: Refresh Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of Wheal and Flare response from histamine skin-prick testing
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Histamine Responsive Allergy PatientsStudies 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 4
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Texas Institute for Clinical Trials
- Sponsor type
- University, hospital or other
- Investigators
- Bob Q Lanier, MD, Principal investigator, North Texas Institute for Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128556
- Sponsor's protocol ID
- MAC-01-10
- Status last verified
- Jul 2010
- First submitted
- 21 May 2010
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effect of Bepreve, a Topical Ocular Antihistamine, on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing
- ClinicalTrials.gov ID
- NCT01128556
- Acronym / sponsor ID
- MAC-01-10
- Conditions
- Histamine Responsive Allergy Patients
- Keywords
- allergic conjunctivitis, histamine skin testing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- North Texas Institute for Clinical TrialsUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 May 2010 (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.
To evaluate the effect of BEPREVE compared to a REFRESH Tears Lubricant eye drop on the measurement of the wheal and flare from histamine skin prick testing. This is an open label, two-week, post-marketing study conducted on histamine responsive patients.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bepreve | Experimental | Drug: Bepreve, Drug: Refresh Tearstopical ocular treatment as indicated |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male and female subjects, 18 to 65 years of age
- Patients must demonstrate a positive reaction to a Histamine skin-prick test. Manifested by a histamine-induced wheal of >3mm in diameter over the normal saline control after 15 minutes of elapsed time
Key exclusion criteria (8 listed)
- Significant signs and symptoms of currently active allergic disease (SAR, perennial allergic rhinitis, episodic allergic rhinitis)
- Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to visit 1
- Subjects who have dermatographism or other skin conditions which might interfere with the interpretation of the skin test results
- Subjects who are receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy
- Known hypersensitivity to the investigational product or to drugs with similar chemical properties
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 |
|---|---|---|
| BepreveAlso: bepotastine besilateBepreve (bepotastine besilate ophthalmic solution 1.5%) one drop in each eye twice daily | Drug | Bepreve |
| Refresh TearsRefresh Tears one drop to each eye twice daily for 7 days after the conclusion of Bepreve treatment | Drug | Bepreve |
Primary outcome
measurement of Wheal and Flare response from histamine skin-prick testing
Time frame: 7 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 8 Jul 2010.
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.
Bob Q Lanier, MD principal investigator
North Texas Institute for Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bepreve and Refresh Tears in people with Histamine Responsive Allergy Patients, run by North Texas Institute for Clinical Trials 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 2 inclusion and 8 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 8 Jul 2010. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
measurement of Wheal and Flare response from histamine skin-prick testing (time frame: 7 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 8 Jul 2010.