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A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication | Clinical Trials | Clareo Health

COMPLETEDNA

A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication

A First-in-human Explorative Pilot Study in Healthy Volunteers Measuring Eye Parameters With a New Mobile Phone Application for Future Monitoring of Patients in Treatment of Substance Use Disorder

NCT05731999•Kontigo Care AB

View on ClinicalTrials.gov

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.

Detailed Description

This first study will give valuable information on the feasibility of Previct Drugs function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of a medicinal product. It will also provide information on the usability of the device. Drug intake will in this first investigation be simulated by a controlled single application of commonly therapeutically used medicinal products from the following classes of drugs: phenethylamines (D1), benzodiazepines (D2), cannabinoids (D3), and opioids (D4).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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 judgement
•Any disease or condition that may influence pupillary reflexes based on clinical judgement
•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
+10 more criteria

Locations (1)

Leiden University Medical Center (LUMC) Department of Anesthesiology

Leiden, Netherlands

Key Dates

Start Date

February 15, 2023

Primary Completion Date

July 19, 2023

Completion Date

July 19, 2023

Last Updated

April 2, 2025

Enrollment

ACTUAL participants

Conditions

Drug Abuse

Interventions

Previct Drugs

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication

Inclusion Criteria

Exclusion Criteria

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