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

North Texas Institute for Clinical Trials

Status and phase

Completed

Phase 4

Conditions

Histamine Responsive Allergy Patients

Treatments

Drug: Bepreve

Drug: Refresh Tears

Study type

Interventional

Funder types

Other

Identifiers

NCT01128556

MAC-01-10

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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