NCT06629740Completed
A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication
A Post-market Clinical Follow-up Investigation in Healthy Volunteers Measuring Eye Parameters to Verify Performance and Safety of Previct® Drugs for Monitoring of Patients in Treatment of Substance Use Disorder
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 1 Oct 2024
- Start date
- 1 Nov 2024
- Primary completion date
- 17 Mar 2025
- Lead sponsor
- Kontigo Care AB
- NCT number
- NCT06629740
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 1 Nov 2024 to the primary completion date, 17 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously participated in the KCClin01 investigation.
- Undergone eye surgery that may influence pupillary reflexes based on clinical judgement.
- Ongoing treatment with medications which may interfere with eye measurements based on clinical judgement.
- Ongoing treatment with medications which may interfere with any of the medicinal products to be used.
Other illness
- Resting heart rate above 90 BPM.
- 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 judgement.
- Any disease or condition that may influence pupillary reflexes based on clinical judgement.
- History or presence of allergy or serious reaction to the medicinal products to be used.
- History or presence of cardiovascular disease, e.g., arteriosclerosis, hypertension, or cor pulmonale.
- History or presence of sleep-related breath disorder.
- History or presence of gastrointestinal disease, e.g., paralytic ileus, acute abdomen, delayed gastric emptying, or chronic constipation.
- History or presence of pulmonary disease, e.g., acute pulmonary insufficiency, severe respiratory depression with hypoxia, chronic obstructive lung disease, or bronchial asthma.
- History or presence of autoimmune neuromuscular disease, e.g., myasthenia gravis.
- Any other condition that as judged by the investigator may make the follow-up or investigation inappropriate.
Other
- Participating in another clinical investigation which may affect the clinical investigation outcome according to clinical judgement.
- Pregnant or lactating.
- Blind and/or deaf.
- Clinically abnormal ECG, according to the investigator. QTcF time above 450 ms at enrollment.
- Not able to read or understand the local language.
Who the study is looking for
- Male or female healthy volunteers.
- Age 18 to 55 years.
- BMI between 18.5-30 kg/m2.
- Weight between 50-100 kg.
- Healthy as determined by the investigator or designee based on pre-investigational medical and surgical history, and 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 clinical investigation 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 set after trying maximum three times per measurement).
- Voluntarily agrees to participate and has duly singed the Informed Consent Form.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leiden University Medical Center (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.