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

NCT01128556 | Completed Phase 4

• 1 other identifier: MAC-01-10
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Histamine Responsive Allergy Patients

Keywords

allergic conjunctivitis; histamine skin testing

Outcome Measures

Primary Outcomes (1)

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

  7 days

Study Arms (1)

Bepreve

EXPERIMENTAL

topical ocular treatment as indicated

Drug: Bepreve; Drug: Refresh Tears

Interventions

Bepreve DRUG

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

Also known as: bepotastine besilate

Bepreve

Refresh Tears DRUG

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

Bepreve

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• North Texas Institute for Clinical Trials: lead

Study Sites (1)

North Texas Institute for Clinical Trials

Fort Worth, Texas, 76132, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

bepotastine besilate

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Bob Q Lanier, MD

  North Texas Institute for Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: May 24, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 8, 2010

Record last verified: 2010-07

Locations

US (1)