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Completed

NCT Number: NCT01128556

The Evaluation of Bepreve 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.

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Key information

Conditions

Histamine Responsive Allergy Patients Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

North Texas Institute for Clinical Trials

Fort Worth, Texas, 76132, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bepreve

Drug

Bepreve (bepotastine besilate ophthalmic solution 1.5%) one drop in each eye twice daily

Other names: bepotastine besilate

Refresh Tears

Drug

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

Primary outcomes

  1. measurement of Wheal and Flare response from histamine skin-prick testing

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

North Texas Institute for Clinical Trials

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 24, 2010
Registry last updated
Jul 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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