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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.