Trial intelligence / Profile preview

Effect of Bepreve on Histamine Skin Prick Test Response

NCT01128556Phase 4

Key facts

Status
Completed
Start
Apr 2010
Primary completion
Jun 2010
Countries
1
Sponsor
North Texas Institute for Clinical Trials
Modality
Small Molecules
Conditions
allergic conjunctivitis (AC)
01

Overview

Phase 4, open-label, single-arm trial of bepotastine in allergic conjunctivitis (AC), sponsored by North Texas Institute for Clinical Trials. Primary endpoint: measurement of Wheal and Flare response from histamine skin-prick testing at 7 days. Started Apr 2010; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Bepreve Sequence

    Bepreve followed by Refresh Tears

03

Who it enrols

Healthy subjects aged 18-65 with a positive histamine skin-prick test (wheal >3mm) are eligible. Patients with active allergic disease symptoms, recent respiratory infections, asthma, dermatographism, or those receiving immunotherapy are excluded.

04

Endpoints

Primary

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

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