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

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ClinicalTrials.gov Identifier: NCT01128556
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : July 8, 2010
Sponsor:
Information provided by:
North Texas Institute for Clinical Trials

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.

Condition or disease Intervention/treatment Phase
Histamine Responsive Allergy Patients Drug: Bepreve Drug: Refresh Tears Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : April 2010
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Tears
U.S. FDA Resources

Arm Intervention/treatment
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



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


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128556


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

Responsible Party: Bob Q. Lanier, M.D., North Texas Institute for Clinical Trials
ClinicalTrials.gov Identifier: NCT01128556     History of Changes
Other Study ID Numbers: MAC-01-10
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: July 8, 2010
Last Verified: July 2010

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

Additional relevant MeSH terms:
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs