The Evaluation of Bepreve on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing
Completed · Phase 4
Conditions studied: Histamine Responsive Allergy Patients
In brief
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.
Key facts
- Study ID
- NCT01128556
- Run by
- North Texas Institute for Clinical Trials
- People needed
- 30
- Starts
- 2010-04-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2010-07-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- North Texas Institute for Clinical Trials — Fort Worth, Texas, United States
Full record on ClinicalTrials.gov
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