Clinical trial NCT05731999: A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Abuse
Lead sponsor: Kontigo Care AB
Sponsor class: INDUSTRY
First posted: 2023-02-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to one out of four arms, i.e., single application of either phenethylamines, benzodiazepines, cannabinoids, or opioids. The investigation aims to enroll 11 subjects, i.e., healthy volunteers, per medicinal product group that have completed the clinical investigation until the telephone follow-up call. For four medicinal products, the total will be 44 subjects. In order to take account for a drop-out rate of 10%, 12 subjects will be included per medicinal product group and in total 48 subjects in the clinical investigation. As this is an early feasibility and explorative investigation, the sample size is not derived from a sample size calculation as no hypothesis is pre-defined.
Primary purpose: OTHER

Brief 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 criteria: 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

Primary outcomes:
measure: 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).
timeFrame: Day 7 +/- 2 days (Visit 2)
Secondary outcomes:
measure: 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).
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms.
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: 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.
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms.
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: 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.
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 1
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 2
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 4
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 5
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 7
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 8
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 9
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 10
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 11
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 12
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 13
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 15
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 16
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 18
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 20
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 21
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 23
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 24
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 26
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 27
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 29
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 31
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 33
timeFrame: Day 7 +/- 2 days (Visit 2)
measure: Usability Questionnaire - Question 34
timeFrame: Day 7 +/- 2 days (Visit 2)
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center (LUMC) Department of Anesthesiology
Study officials:
affiliation: Kontigo Care AB
name: Markku Hämäläinen, PhD
role: STUDY_CHAIR
References: