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

Sponsor
North Texas Institute for Clinical Trials (Other)
Overall Status
Completed
CT.gov ID
NCT01128556
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
2
Duration (Months)
15
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 1, 2010
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

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 Names:
  • bepotastine besilate

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

    Outcome Measures

    Primary Outcome Measures

    1. measurement of Wheal and Flare response from histamine skin-prick testing [7 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01128556
    Other Study ID Numbers:
    • MAC-01-10
    First Posted:
    May 24, 2010
    Last Update Posted:
    Jul 8, 2010
    Last Verified:
    Jul 1, 2010
    Keywords provided by , ,
    allergic conjunctivitis
    histamine skin testing
    Additional relevant MeSH terms:
    Bepotastine besilate

    Study Results

    No Results Posted as of Jul 8, 2010