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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01128556

Enrollment

Registered

2010-05-24

Start date

2010-04-30

Completion date

2010-06-30

Last updated

2010-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Histamine Responsive Allergy Patients

Keywords

allergic conjunctivitis, histamine skin testing

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.

Interventions

DRUGBepreve

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

DRUGRefresh Tears

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026