A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication (NCT06629740) | Clinical Trial Compass
CompletedNot Applicable
A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication
Netherlands34 participantsStarted 2024-11-01
Plain-language summary
This is a post-market clinical follow-up study on an approved CE-marked eHealth system where a mobile phone application is used to measure the pupils and eye measurements to monitor the use of different drug substances. The goal of the study is to collect additional information when using the system and to improve the current models for indicating the use of cannabinoids and phenethylamines.
Drug intake of cannabinoid or phenethylamine will in this study be simulated using two commonly used medicines.
The study will include healthy volunteers where each participant will participate in the study for approximately 10 days. The participant will be using the mobile phone application for about a week, first at the clinic and then in the home environment. After approximately a week the participant will visit the clinic to be administered with the selected medicine whereafter the mobile phone application will be used for up to 5 hours. A final phone call will be taken place at approximately day 10, whereafter the participant has completed the study.
Who can participate
Age range18 Years ā 55 Years
SexALL
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Inclusion criteria
ā. Male or female healthy volunteers.
ā. Age 18 to 55 years.
ā. BMI between 18.5-30 kg/m2.
ā. Weight between 50-100 kg.
ā. Healthy as determined by the investigator or designee based on pre-investigational medical and surgical history, and health examination at enrollment.
ā. Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to enrollment) must have a negative urine pregnancy test at enrollment and at visit 2 and must agree to use a medically acceptable contraception from enrollment until clinical investigation completion.
ā. No current drug usage defined as a negative urine drug test at enrollment and at visit 2.
ā. Able to use Previct Drugs after initial training (defined as successfully performing a test set after trying maximum three times per measurement).
Exclusion criteria
ā
What they're measuring
1
Verify if self-administered eye scanning using a mobile phone application, using native key features (alone or in predefined combination(s)), can indicate use of each medicine (D1-D2).