The Evaluation of Bepreve on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: North Texas Institute for Clinical Trials
• Treatments: Bepotastine besilate; Histamine; Histamine phosphate

Criteria

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