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

This study has been completed.
Information provided by:
North Texas Institute for Clinical Trials Identifier:
First received: May 21, 2010
Last updated: July 7, 2010
Last verified: July 2010
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.

Condition Intervention Phase
Histamine Responsive Allergy Patients
Drug: Bepreve
Drug: Refresh Tears
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: The Evaluation of the Effect of Bepreve, a Topical Ocular Antihistamine, on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing

Resource links provided by NLM:

Further study details as provided by North Texas Institute for Clinical Trials:

Primary Outcome Measures:
  • measurement of Wheal and Flare response from histamine skin-prick testing [ Time Frame: 7 days ]

Estimated Enrollment: 30
Study Start Date: April 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bepreve
topical ocular treatment as indicated
Drug: Bepreve
Bepreve (bepotastine besilate ophthalmic solution 1.5%) one drop in each eye twice daily
Other Name: bepotastine besilate
Drug: Refresh Tears
Refresh Tears one drop to each eye twice daily for 7 days after the conclusion of Bepreve treatment


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01128556

United States, Texas
North Texas Institute for Clinical Trials
Fort Worth, Texas, United States, 76132
Sponsors and Collaborators
North Texas Institute for Clinical Trials
Principal Investigator: Bob Q Lanier, MD North Texas Institute for Clinical Trials
  More Information

Responsible Party: Bob Q. Lanier, M.D., North Texas Institute for Clinical Trials Identifier: NCT01128556     History of Changes
Other Study ID Numbers: MAC-01-10
Study First Received: May 21, 2010
Last Updated: July 7, 2010

Keywords provided by North Texas Institute for Clinical Trials:
allergic conjunctivitis
histamine skin testing

Additional relevant MeSH terms:
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2017