N/A
Completed N=48
A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication
Drug Abuse
Source: ClinicalTrials.gov NCT05731999 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: 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). — 295; 286; 317; 300 Number of attempts
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
295; 286; 317; 300; 279; 242 | — |
| SECONDARY 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). |
296; 282; 318; 297; 281; 241 | — |
| SECONDARY Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms. |
5; 1; 4; 7; 5; 3 | — |
| SECONDARY 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. |
5; 6; 7; 10; 7; 4 | <0.0001 sig |
| SECONDARY Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms. |
6; 1; 2; 8; 5; 5 | — |
| SECONDARY 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. |
12; 12; 12; 10; 11; 12 | <0.05 sig |
| SECONDARY Usability Questionnaire - Question 1 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Usability Questionnaire - Question 2 |
11; 12; 12; 12; 1; 0 | — |
| SECONDARY Usability Questionnaire - Question 4 |
11; 8; 5; 6; 1; 4 | — |
| SECONDARY Usability Questionnaire - Question 5 |
12; 10; 9; 11; 0; 2 | — |
| SECONDARY Usability Questionnaire - Question 7 |
5; 5; 5; 4; 7; 5 | — |
| SECONDARY Usability Questionnaire - Question 8 |
4; 3; 4; 4; 8; 9 | — |
| SECONDARY Usability Questionnaire - Question 9 |
1; 2; 2; 1; 3; 1 | — |
| SECONDARY Usability Questionnaire - Question 10 |
5; 2; 3; 2; 5; 6 | — |
| SECONDARY Usability Questionnaire - Question 11 |
2; 4; 2; 4; 2; 0 | — |
| SECONDARY Usability Questionnaire - Question 12 |
5; 9; 3; 8; 7; 3 | — |
| SECONDARY Usability Questionnaire - Question 13 |
0; 1; 2; 2; 12; 11 | — |
| SECONDARY Usability Questionnaire - Question 15 |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Usability Questionnaire - Question 16 |
1; 1; 3; 2; 7; 10 | — |
| SECONDARY Usability Questionnaire - Question 18 |
5; 6; 6; 4; 6; 6 | — |
| SECONDARY Usability Questionnaire - Question 20 |
3; 3; 2; 2; 7; 6 | — |
| SECONDARY Usability Questionnaire - Question 21 |
7; 8; 4; 1; 5; 2 | — |
| SECONDARY Usability Questionnaire - Question 23 |
5; 6; 4; 4; 4; 3 | — |
| SECONDARY Usability Questionnaire - Question 24 |
5; 5; 4; 5; 5; 6 | — |
| SECONDARY Usability Questionnaire - Question 26 |
4; 6; 1; 4; 7; 5 | — |
| SECONDARY Usability Questionnaire - Question 27 |
10; 9; 7; 6; 2; 2 | — |
| SECONDARY Usability Questionnaire - Question 29 |
2; 2; 4; 1; 6; 5 | — |
| SECONDARY Usability Questionnaire - Question 31 |
5; 7; 6; 4; 5; 3 | — |
| SECONDARY Usability Questionnaire - Question 33 |
4; 0; 1; 1; 5; 9 | — |
| SECONDARY Usability Questionnaire - Question 34 |
5; 2; 5; 3; 3; 4 | — |
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
Data sourced from ClinicalTrials.gov (NCT05731999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.