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

This study has been completed.
Sponsor:
Information provided by:
North Texas Institute for Clinical Trials
ClinicalTrials.gov Identifier:
NCT01128556
First received: May 21, 2010
Last updated: July 7, 2010
Last verified: July 2010
  Purpose

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
Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 21, 2010
Last Updated: July 7, 2010
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014