DropMeter interest in clinical trials

Session Details

Session Title: Presented Poster Session: Infections & Syndromes

Venue: Poster Village: Pod 3

First Author: : D.Renault FRANCE

Co Author(s): :    G. Garhofer   E. Courrier   H. Rebika   G. Thuret   P. Gain           

Abstract Details

Purpose:

To describe the different ways to use a dropmeter in dry eye clinical study.

Setting:

University Hospital of Saint-Etienne, Department of Ophthalmology, France

Methods:

International, prospective, randomised, and controlled Phase III. In this trial, the dropmeter, a 3G wireless device that records and transmits topical medication use in real time, will be used to count all concomitant drops of saline solution during screening, both 6-month randomised and open clinical phases in addition to the studied drug. As conjunctival cul-de-sac volume is only (7 µL), even if two consecutive instillations in less than 5 minutes was administered, it will be counted as only one.

Results:

247 patients suffering from dry eye syndrome were enrolled in 20 countries. In all countries the device works well. A total 247.096 drops have been counted. The number of instillations is used by investigators as a study inclusion criteria. Dropmeter can also differentiate patient habits during screening period and we can show different patient patterns according to the daily use of these additional drops need for the different patient categories. In a second time, at the end of the study, we will compare the use of saline solution in both arms.

Conclusions:

Dropmeter could be used to follow the patient compliance but also control the use of concomitant treatments in studies (including daily use, preferred drops or tapering period…) or in the real life. This tool is especially interesting to obtain more accurate data concerning patient’s instillations and compliance in order to avoid a daily reporting of all instillations witch is often not done. Also additional subgroup analysis could done with different dry eye disease etiologies.

Financial Disclosure:

None