Skip to main content
OpenTrials
Completed

NCT Number: NCT05731999

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

This is a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data on the medical device Previct Drugs.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Drug Abuse Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center (LUMC) Department of Anesthesiology

Leiden, 2333 ZA, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Ongoing treatment with medications which may interfere with any of the medicinal products to be used
  • 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
  • Not able to read or understand the local language
  • Any other condition that as judged by the investigator may make the follow-up or investigation inappropriate
  • That according to the Declaration of Helsinki is deemed unsuitable for study enrollment

Treatment and study plan

Previct Drugs

Device

Previct Drugs is a new non CE-marked eHealth system intended to be used for future monitoring and treatment of patients with substance use disorder (SUD). Previct Drugs consists of an application (app) to be installed on a smartphone, a web-based careportal to be accessed from a computer by the healthcare professional for administration and access of registered data, and a database for storage, handling, and analysis of reported data. Previct Drugs is intended to be used by healthcare professionals and patients within treatment of SUD.

Primary outcomes

  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).

    Time frame: Day 7 +/- 2 days (Visit 2)

    For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using native pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an "Attempt", and the successful transformation is denoted a "Successful attempt".

Secondary outcomes

  1. Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4).

    Time frame: Day 7 +/- 2 days (Visit 2)

    For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using refined pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an "Attempt", and the successful transformation is denoted a "Successful attempt.

  2. Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms.

    Time frame: Day 7 +/- 2 days (Visit 2)

    For each medicinal product (D1-D4), number of changed key features from baseline to the LC-MS/MS (Liquid Chromatography Tandem Mass-Spectroscopy) verified peak concentration in plasma after administration of medicinal product at visit 2 using refined pupillograms. Each of the 24 key features represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "changed" if the difference between averages at baseline and peak concentration is significant (p<0.05). Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions.

  3. Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition.

    Time frame: Day 7 +/- 2 days (Visit 2)

    For each medicinal product (D1-D4), number of significant correlations between key features and plasma concentration over time using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "correlated" if the slope in a linear regression is significantly different from zero (p<0.05). The term correlated over time refers to data collected during 5 hours at Visit 2 after administration of D1-D4. Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions.

  4. Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms.

    Time frame: Day 7 +/- 2 days (Visit 2)

    For each medicinal product (D1-D4), number of changed key features from baseline to 5 hours after administration of medicinal product at visit 2 using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "changed" if the difference between averages at baseline and at 5 hours is significant (p<0.05). Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions.

  5. Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition.

    Time frame: Day 7 +/- 2 days (Visit 2)

    For each medicinal product (D1-D4), evaluate known combinations of key features that changes from baseline to the LC-MS/MS verified peak concentration in plasma after administration of medicinal product at visit 2 using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A combination of key features collected at peak plasma concentration was used to build a logistic regression classifier, and the resulting counts of true positives, true negatives, false positives, and false negatives are presented. Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. Key feature values were missing in a few instances, as shown in the table.

  6. Usability Questionnaire - Question 1

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 1. How would you grade the instructions for use?

    Response options:

    • Not understandable
    • Could only understand some parts
    • Could understand most parts
    • Could understand almost every part
    • Fully understandable

  7. Usability Questionnaire - Question 2

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 2. Was Previct Drugs easy to use correctly based on the information in the Instructions For Use (IFU)?

    Response options:

    • Yes
    • No

  8. Usability Questionnaire - Question 4

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 4. How did you experience the verbal instructions during a test with Previct Drugs?

    Response options:

    • Very easy to understand
    • Easy to understand
    • Nor easy or difficult to understand
    • Difficult to understand
    • Very difficult to understand

  9. Usability Questionnaire - Question 5

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 5. Before starting a test, the App prompted you with a few written instructions. Did you read the instructions?

    Response options:

    • Yes
    • No

  10. Usability Questionnaire - Question 7

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 7. How did you experience performing a test with Previct Drugs (from opening of the App until the test was completed)?

    Response options:

    • Very easy to perform
    • Easy to perform
    • Nor easy or difficult to perform
    • Difficult to perform
    • Very difficult to perform

  11. Usability Questionnaire - Question 8

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 8. During a test with Previct Drugs, did you at any time have to tilt the mobile against something to be able to perform a measurement?

    Response options:

    • Yes
    • No

  12. Usability Questionnaire - Question 9

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2.

    Question 9. If Yes (to question 8), how often did you have to tilt the mobile against something:

    Response options:

    • One occasion
    • Several occasions
    • Most occasions
    • All occasions

  13. Usability Questionnaire - Question 10

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 10. According to you, how many minutes did a test with Previct Drugs take in general? From start to end.

    Response options:

    • < 5 minutes
    • 5-7 minutes
    • > 7 minutes

  14. Usability Questionnaire - Question 11

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 11. Did you receive a notification when it was time for a test with Previct Drugs?

    Response options:

    • Yes
    • Most of the times
    • I did not receive any notifications

  15. Usability Questionnaire - Question 12

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 12. Did you notice any issues during usage of Previct Drugs?

    Response options:

    • No
    • Yes

  16. Usability Questionnaire - Question 13

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 13. Did you require any assistance from the study personnel (e.g., through phone) during the usage of Previct Drugs?

    Response options:

    • Yes
    • No

  17. Usability Questionnaire - Question 15

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 15. If Yes (to question 13), how often did you require assistance?

    Response options:

    • One occasion
    • Several occasions
    • Most occasions
    • All occasions

  18. Usability Questionnaire - Question 16

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 16. When starting a measurement, how was your experience finding the right conditions to start the measurement?

    Response options:

    • Very easy
    • Easy
    • Nor easy or difficult
    • Difficult
    • Very difficult

  19. Usability Questionnaire - Question 18

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 18. How did you experience performing a Nystagmus (look to your extreme right and left) test?

    Response options:

    • Very easy to perform
    • Easy to perform
    • Nor easy or difficult to perform
    • Difficult to perform
    • Very difficult to perform

  20. Usability Questionnaire - Question 20

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 20. According to you, how many minutes did a Nystagmus test take (from starting test until analyzed)?

    Response options:

    • < 1 minute
    • 1-2 minutes
    • > 3 minutes

  21. Usability Questionnaire - Question 21

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 21. How often did you have to redo a Nystagmus test?

    Response options:

    • No occasion
    • One occasion
    • Several occasions
    • Most occasions
    • All occasions

  22. Usability Questionnaire - Question 23

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 23. In general, how easy is it for you to cross your eyes?

    Response options:

    • Very easy
    • Easy
    • Nor easy or difficult
    • Difficult
    • Very difficult

  23. Usability Questionnaire - Question 24

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 24. How did you experience performing a Cross Eyes test?

    Response options:

    • Very easy to perform
    • Easy to perform
    • Nor easy or difficult to perform
    • Difficult to perform
    • Very difficult to perform

  24. Usability Questionnaire - Question 26

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 26. According to you, how many minutes did a Cross Eyes test take (from starting until analyzed)?

    Response options:

    • < 1 minute
    • 1-2 minutes
    • > 3 minutes

  25. Usability Questionnaire - Question 27

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 27. How often did you have to redo a Cross Eyes test?

    Response options:

    • No occasion
    • One occasion
    • Several occasions
    • Most occasions
    • All occasions

  26. Usability Questionnaire - Question 29

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 29. How did you experience performing a Contraction test?

    Response options:

    • Very easy to perform
    • Easy to perform
    • Nor easy or difficult to perform
    • Difficult to perform
    • Very difficult to perform

  27. Usability Questionnaire - Question 31

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 31. How was your experience turning your mobile when asked to?

    Response options:

    • Very easy to perform
    • Easy to perform
    • Nor easy or difficult to perform
    • Difficult to perform
    • Very difficult to perform

  28. Usability Questionnaire - Question 33

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 33. According to you, how many minutes did a Contraction test take (from starting test until analyzed)?

    Response options:

    • < 1 minute
    • 1-2 minutes
    • > 3 minutes

  29. Usability Questionnaire - Question 34

    Time frame: Day 7 +/- 2 days (Visit 2)

    User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 34. How often did you have to redo a Contraction test?

    Response options:

    • No occasion
    • One occasion
    • Several occasions
    • Most occasions
    • All occasions

Sponsors and collaborators

Lead sponsor

Kontigo Care AB

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.