The Evaluation of Bepreve on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing
Phase 4
Completed
- Conditions
- Histamine Responsive Allergy Patients
- Interventions
- Registration Number
- NCT01128556
- Lead Sponsor
- North Texas Institute for Clinical Trials
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Bepreve Refresh Tears topical ocular treatment as indicated Bepreve Bepreve topical ocular treatment as indicated
- Primary Outcome Measures
Name Time Method measurement of Wheal and Flare response from histamine skin-prick testing 7 days
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of Bepreve's antihistamine action influence wheal and flare responses in histamine-sensitive patients?
How does Bepreve's efficacy in modulating histamine-induced skin reactions compare to standard ocular antihistamines like Alcon's Claritin Eye or Zaditor?
Are there specific biomarkers in histamine responsive allergy patients that correlate with Bepreve's impact on wheal and flare measurements?
What adverse events are associated with Bepreve use in histamine responsive patients and how do they compare to artificial tears?
How does Bepreve's pharmacological profile compare to other topical antihistamines like Pataday or Lastacaft in allergy management?
Trial Locations
- Locations (1)
North Texas Institute for Clinical Trials
🇺🇸Fort Worth, Texas, United States
North Texas Institute for Clinical Trials🇺🇸Fort Worth, Texas, United States