A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before a… (NCT05731999) | Clinical Trial Compass
CompletedNot Applicable
A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication
Netherlands48 participantsStarted 2023-02-15
Plain-language summary
This is a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data on the medical device Previct Drugs.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female healthy volunteers
* Age 18 to 70 years
* BMI between 18.5-30 kg/m2
* Weight between 50-100 kg
* Healthy as determined by the investigator or designee based on pre-study medical and surgical history and a health examination at enrollment
* 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 study completion
* No current drug usage defined as a negative urine drug test at enrollment and at visit 2
* Able to use Previct Drugs after initial training (defined as successfully performing a test after trying maximum three times per measurement)
* Been informed of the nature, the scope, and the relevance of the clinical investigation
* Voluntarily agreed on participation and has duly singed the Informed Consent Form
Exclusion Criteria:
* Participating in another clinical investigation which may affect the study outcome according to clinical judgement
* Pregnancy or Lactating
* Blind
* Deaf
* Abnormal ECG (QTc time \>450 ms) at enrollment
* Current or recent history of alcohol misuse assessed by AUDIT where ≥6 points for women or ≥8 points for men indicates a potential misuse
* Current or history of psychiatric disorder or drug misuse assessed by M.I.N.I where the outcome will be based on clinical judgemen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4).