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

NCT05731999 | Completed Results

• 1 other identifier: KCClin01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Abuse

Outcome Measures

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).

  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".

  Day 7 +/- 2 days (Visit 2)

Secondary Outcomes (29)

• 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).

  Day 7 +/- 2 days (Visit 2)

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

  Day 7 +/- 2 days (Visit 2)

• 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.

  Day 7 +/- 2 days (Visit 2)

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

  Day 7 +/- 2 days (Visit 2)

• 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.

  Day 7 +/- 2 days (Visit 2)

Study Arms (4)

Single application of phenethylamines (D1)

EXPERIMENTAL

Evaluation 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 phenethylamines.

Device: Previct Drugs

Single application of benzodiazepines (D2)

EXPERIMENTAL

Evaluation 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 benzodiazepines.

Device: Previct Drugs

Single application of cannabinoids (D3)

EXPERIMENTAL

Evaluation 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 cannabinoids.

Device: Previct Drugs

Single application of opioids (D4)

EXPERIMENTAL

Evaluation 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 opioids.

Device: Previct Drugs

Interventions

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.

Single application of benzodiazepines (D2); Single application of cannabinoids (D3); Single application of opioids (D4); Single application of phenethylamines (D1)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kontigo Care AB: lead

Study Sites (1)

Leiden University Medical Center (LUMC) Department of Anesthesiology

Leiden, 2333 ZA, Netherlands

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Markku Hämälainen, CSO
• Organization: Kontigo Care AB

markku.hamalainen@kontigocare.com

+46 (0)76 947 3132

Study Officials

• Markku Hämäläinen, PhD

  Kontigo Care AB

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 16, 2023
• Study Start: February 15, 2023
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: April 2, 2025
• Results First Posted: April 2, 2025

Record last verified: 2025-04

Locations

NL (1)