A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication

Kontigo Care AB34 enrolled

Overview

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.

This is a controlled, prospective, post-market clinical follow-up study that aims to collect additional data on performance and safety of the CE-marked eHeatlh system Previct Drugs. Previct Drugs is intended to be used in treatment of substance use disorder (SUD) to support and monitor patients' treatment. The system relies on self-administered eye scanning performed with a mobile phone application where the analysis of the eye´s reaction on intake of drug substances gives an indication of different drug substances. The clinical data collected in this study is an important step to verify and improve the algorithms of Previct Drugs, and to improve the mathematical models for indicating the use of the substances cannabinoids and phenethylamines. Drug intake will in this study be simulated by a controlled single application of commonly used medicines from cannabinoids and phenethylamine. The study will enroll and follow 30 male and female healthy volunteers for participation of approximately 10 days. The study will consist of two visits to the clinic, and one follow-up telephone call before the participant has completed the study. Baseline data will be collected at the first visit on Day 0, including usage of Previct Drugs, followed by usage of Previct Drugs in the home environment for about one week. At visit 2 on Day 7, the subject will be administered with the medicine he/she has been randomized to and thereafter use Previct Drugs for up to 5 hours. A final follow-up telephone call will take place approximately at day 10 before the participant has completed the study.

Study Type

Interventions

Measurements with a eHealth systemDEVICE

The eHealth system Previct Drugs is a CE marked medical device intended to be used in treatment of substance use disorder (SUD) to support and monitor patients' treatment. Previct Drugs consists of a mobile phone application used to perform self-administered eye-scanning, a web-based careportal used by the caregiver, a database for storage, handling, and analysis of reported data, and an admin portal for the manufacturer to register and administer customers. In this study, Previct Drugs will be used by healthy volunteers for performing measurements before and after intake of a commonly used medicine to simulate drug intake.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female healthy volunteers. 2. Age 18 to 55 years. 3. BMI between 18.5-30 kg/m2. 4. Weight between 50-100 kg. 5. Healthy as determined by the investigator or designee based on pre-investigational medical and surgical history, and health examination at enrollment. 6. 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. 7. No current drug usage defined as a negative urine drug test at enrollment and at visit 2. 8. Able to use Previct Drugs after initial training (defined as successfully performing a test set after trying maximum three times per measurement). 9. Voluntarily agrees to participate and has duly singed the Informed Consent Form. Exclusion Criteria: 1. Participating in another clinical investigation which may affect the clinical investigation outcome according to clinical judgement. 2. Previously participated in the KCClin01 investigation. 3. Pregnant or lactating. 4. Blind and/or deaf. 5. Clinically abnormal ECG, according to the investigator. QTcF time above 450 ms at enrollment. 6. Resting heart rate above 90 BPM. 7. Current or recent history of alcohol misuse assessed by AUDIT where ≥6 points for women or ≥8 points for men indicates a potential misuse. 8. Current or history of psychiatric disorder or drug misuse assessed by M.I.N.I where the outcome will be based on clinical judgement. 9. Any disease or condition that may influence pupillary reflexes based on clinical judgement. 10. Undergone eye surgery that may influence pupillary reflexes based on clinical judgement. 11. Ongoing treatment with medications which may interfere with eye measurements based on clinical judgement. 12. Ongoing treatment with medications which may interfere with any of the medicinal products to be used. 13. History or presence of allergy or serious reaction to the medicinal products to be used. 14. History or presence of cardiovascular disease, e.g., arteriosclerosis, hypertension, or cor pulmonale. 15. History or presence of sleep-related breath disorder. 16. History or presence of gastrointestinal disease, e.g., paralytic ileus, acute abdomen, delayed gastric emptying, or chronic constipation. 17. History or presence of pulmonary disease, e.g., acute pulmonary insufficiency, severe respiratory depression with hypoxia, chronic obstructive lung disease, or bronchial asthma. 18. History or presence of autoimmune neuromuscular disease, e.g., myasthenia gravis. 19. Not able to read or understand the local language. 20. Any other condition that as judged by the investigator may make the follow-up or investigation inappropriate.

Outcomes

Primary Outcomes

Verify if Self-administered Eye Scanning Using a Mobile Phone Application, Using Native Key Features (Alone or in Predefined Combination(s)), Can Indicate Use of Each Medicine (D1-D2).

For each medicinal product (D1-D2), 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 native pupillograms. Each of the 21 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.

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

Secondary Outcomes

Verify if Self-administered Eye Scanning Using a Mobile Phone Application, After Refinement of the Method for Establishing Key Features (Alone or in Predefined Combination(s)), Can Indicate the Use of Each Medicine (D1-D2).

For each medicinal product (D1-D2), 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 21 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.

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

Evaluate the First and Last Measurement Occasion After Medicine Intake of D1 or D2 When Refined Key Eye Features, Alone or in Predefined Combination(s), Differ From Baseline.

For each medicinal product, refined pupillogram key features were evaluated for significant change from baseline at predefined post-dose measurement occasions. The reported value is the first or last scheduled measurement occasion start time at which a statistically significant change from baseline was observed for the study population. Values therefore represent study-level time-point identifiers from a significance analysis and are not participant-level measurements; measures of central tendency and dispersion are not applicable. Up to 5 key features with the lowest p-values were reported separately for each ambient light condition (50 lux and 500 lux). Consequently, 8 key features were reported for cannabinoid (3 at 50 lux and 5 at 500 lux) and 10 for phenethylamine (5 at 50 lux and 5 at 500 lux). Measurement occasions were 10\*, 30, 60, 120, 180, 240, 360 and 420¤ min post-dose (\*cannabinoid only; ¤phenethylamine only).

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

Evaluate the Difference Between Refined Drug naïve Test Data Collected at the Clinic and Compared With Tests Performed in Home Environment.

For each subject, differences between refined key feature values taken at baseline (at study site) and measurements taken in home environment under similar light conditions. This outcome relates to data collected prior to administration of medicinal product, meaning the two arms contain data from identical conditions and can be merged into one group. Reporting is performed only for Dbase, Dcon, MCA, MCV. Two different ambient light conditions, as measured with the smartphones, is compared for dimmed (20-150 Lux) and bright (150-500 Lux) light. When the difference between data from baseline (at the clinic) and data from home condition is non-significant (using p\<0.05 as significance level), then the key feature is reported similar for the designated ambient light condition.

Time frame: From Day 0 to Day 7 (+ 2 days)

Evaluate if the Refined Drug naïve Key Features (Alone or in Predefined Combination(s)), Collected at Baseline Differs From Data Collected at Peak Plasma Concentration Under the Influence of D1-D2 Without Compensating for Intra-individual Variation.

For each medicinal product, refined pupillogram key features were evaluated for change between baseline and the LC-MS/MS-verified peak plasma concentration following administration at Visit 2. A key feature represents an ocular characteristic derived from the pupillogram (e.g., pupil size or iris position). Unlike the primary, secondary 1 and secondary 2 analysis, baseline values were not normalized for intra-individual variation. For each selected key feature, measurements obtained at peak concentration were compared with baseline measurements across participants. A key feature was counted as changed if the baseline-versus-peak comparison was statistically significant (p\<0.05). Results are reported as the number of changed key features among the five selected key features for reporting in Secondary Outcome 1 (up to five key features with the lowest p-values for each ambient light condition). Key features were evaluated under dim (50 lux) and bright (500 lux) ambient light conditions.

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

Incidence and Severity of Adverse Events.

The incidence and severity of adverse events associated with Previct Drugs.

Time frame: From enrollment until end of follow-up, up to telephone follow-up call latest at Day 14.

A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes