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

July 7, 2010 updated by: North Texas Institute for Clinical Trials

The Evaluation of the Effect of Bepreve, a Topical Ocular Antihistamine, on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76132
        • North Texas Institute for Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Texas Institute for Clinical Trials

Investigators

  • Principal Investigator: Bob Q Lanier, MD, North Texas Institute for Clinical Trials

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

May 21, 2010

First Submitted That Met QC Criteria

May 21, 2010

First Posted (ESTIMATE)

May 24, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 8, 2010

Last Update Submitted That Met QC Criteria

July 7, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAC-01-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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