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

Overview

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.

Full Title of Study: “The Evaluation of the Effect of Bepreve, a Topical Ocular Antihistamine, on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label)
• Study Primary Completion Date: June 2010

Interventions

• Drug: Bepreve
  • Bepreve (bepotastine besilate ophthalmic solution 1.5%) one drop in each eye twice daily
• Drug: Refresh Tears
  • Refresh Tears one drop to each eye twice daily for 7 days after the conclusion of Bepreve treatment

Arms, Groups and Cohorts

• Experimental: Bepreve
  • topical ocular treatment as indicated

Clinical Trial Outcome Measures

Primary Measures

• measurement of Wheal and Flare response from histamine skin-prick testing
  • Time Frame: 7 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • North Texas Institute for Clinical Trials
• Provider of Information About this Clinical Study
  • Bob Q. Lanier, M.D., North Texas Institute for Clinical Trials
• Overall Official(s)
  • Bob Q Lanier, MD, Principal Investigator, North Texas Institute for Clinical Trials