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: Drug: Bepreve; Drug: Refresh Tears

• 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

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-07
• Last Update Posted: 2010-07-08

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

Trial Locations

Locations (1)

North Texas Institute for Clinical Trials; 🇺🇸 Fort Worth, Texas, United States