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

NCT ID: NCT01128556

Last Updated: 2010-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-06-30

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.

Conditions

Histamine Responsive Allergy Patients

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Bepreve

topical ocular treatment as indicated

Group Type: EXPERIMENTAL

Bepreve

Intervention Type: DRUG

Bepreve (bepotastine besilate ophthalmic solution 1.5%) one drop in each eye twice daily

Refresh Tears

Intervention Type: DRUG

Refresh Tears one drop to each eye twice daily for 7 days after the conclusion of Bepreve treatment

Interventions

Bepreve

Bepreve (bepotastine besilate ophthalmic solution 1.5%) one drop in each eye twice daily

Intervention Type: DRUG

Refresh Tears

Refresh Tears one drop to each eye twice daily for 7 days after the conclusion of Bepreve treatment

Intervention Type: DRUG

Other Intervention Names

bepotastine besilate

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

North Texas Institute for Clinical Trials

OTHER

Sponsor Role: lead

Responsible Party

North Texas Institute for Clinical Trials

Principal Investigators

Bob Q Lanier, MD

Role: PRINCIPAL_INVESTIGATOR

North Texas Institute for Clinical Trials

Locations

North Texas Institute for Clinical Trials

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

MAC-01-10

Identifier Type: -

Identifier Source: org_study_id