A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication (NCT06629740), a randomized na study. The primary outcome is 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)..

2. Clinical Question

The study’s stated purpose is to gather post-market information and refine models intended to indicate use of cannabinoids and phenethylamines. Its measurements focus on whether the application can capture eye-feature changes after medicine intake. The registry record describes self-administered eye scanning, with use first at the clinic and then in the home environment, followed by clinic administration of the selected medicine and further measurements.

This is a measurement-performance question in healthy volunteers, not a test of treatment for substance use disorder. The study uses medicines to simulate drug intake; the identity of those medicines is not reported in the registry record. The primary endpoint concerns counts of features meeting a statistical criterion, rather than a single clinical outcome or a direct measure of substance-use behavior.

3. Trial Design

NCT06629740 is listed as a completed, randomized, unmasked, parallel-group study with enrollment of 34. The sponsor is Kontigo Care AB. The registry record lists a start date of 2024-11-01 and primary completion date of 2025-03-17. The study is classified as phase NA.

Participants were healthy volunteers, each expected to take part for approximately 10 days. The record describes application use for about a week, beginning at the clinic and continuing at home. After approximately a week, participants returned to the clinic for administration of a selected medicine, then used the application for up to 5 hours. A final phone call was planned at approximately day 10. The exact visit schedule and any deviations from it are not reported in the registry record.

The two listed groups are Cannabinoid and Phenethylamine. Each group description refers to a single administration and use of the CE-marked eHealth system before and after intake. Randomization is reported, but the allocation procedure, allocation ratio, and sequence-generation method are not reported in the registry record. Masking is listed as none. The record does not describe a placebo or an untreated randomized group.

The primary outcome is assessed on Day 7 (+/- 2 days), in the FAS population. For each medicine, the outcome counts native key features that differ from baseline to the LC-MS/MS-verified peak concentration. Measurements are reported under two ambient-light conditions: 50 Lux and 500 Lux. The record also lists five secondary outcome descriptions, including refined eye features, comparisons of clinic and home measurements, and adverse events. It lists 6 outcome measures and 83 analyses; the detailed numerical findings for the primary endpoint are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: 34 subjects were enrolled into the clinical study of which 31 subjects were identified to to be eligible for study participation after the screening period, i.e., 3 subjects were screening failures. Of the 31 eligible subjects, 19 subjects were randomized to the cannabinoid group and 12 subjects to the phenethylamine group.

Overall Study

Analysis population for the primary outcome, as defined in the registry: FAS population.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: For the presentation of baseline measures, the full analysis set (FAS) was used. FAS included all subjects that fullfilled the following criteria: 1) enrolled, 2) performed at least 2 eye scanning tests with Previct Drugs under ifluence of cannabinoid or phenethylamine, 3) minimum peak concentration of 5 ng/ml (cannabinoid) or 20 ng/ml (phenethylamine). In total 30 subjects were included in the FAS, 18 subjects in the cannabinoid group, and 12 subjects in the phenethylamine group.

6. Primary Endpoint

The registry lists the primary outcome as 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)., measured over Day 7 (+/- 2 days).

The primary endpoint is the number of changed native key features for each medicine, assessed from baseline to the LC-MS/MS-verified peak plasma concentration after administration. The registry record says each of the 21 key features represents an eye characteristic, such as pupil size or iris position. A feature is counted as changed when the difference between the averages at baseline and peak concentration is statistically significant at p < 0.05.

Measurements were taken under dim ambient light (50 Lux) and bright ambient light (500 Lux), and the endpoint is reported for both conditions. This separates the feature-count question by lighting context rather than treating all measurements as interchangeable. The specified timeframe is Day 7 (+/- 2 days), and the population is the FAS population.

The endpoint is used to assess whether the application’s native eye features vary between baseline and peak concentration after medicine intake. Counting features can describe how many measures meet the chosen statistical threshold, but the count does not by itself show the size of each change, its direction, or its practical importance. Numerical endpoint results, including the counts for each medicine and light condition, are not reported in the registry record. The exact statistical tests used to determine whether a feature changed are also not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a significance threshold mean?

General statistical explanation: a significance threshold is a rule for deciding whether observed data are sufficiently inconsistent with a specified null model under the assumptions of the test. The registry record uses p < 0.05 to define when a key feature is counted as changed. A p-value is not the size of the difference, and it is not the probability that the null hypothesis is true. The record does not identify the specific test or model used for each feature, so the assumptions behind those tests cannot be assessed from the registry information.

The endpoint compares averages at baseline and peak concentration. An average gives a summary of measurements, but it can conceal variation among participants or differences in the shape of the data. The registry record does not state whether the averages are participant-level summaries, how repeated observations were handled, or whether the comparison accounts for within-participant dependence. Those analytic details are not reported in the registry record.

Why report results separately by lighting condition?

The study collects measurements in dim ambient light (50 Lux) and bright ambient light (500 Lux), and the endpoint is reported for both conditions. General statistical explanation: measurement context can affect the values recorded by an instrument, so separating results by context helps distinguish performance under the conditions actually assessed. A direct claim that one condition gives better measurement performance would require the relevant results and a defined comparison. Such a conclusion is not possible from the endpoint description alone.

Why does the number of analyses matter?

The record lists 83 analyses, and the primary endpoint concerns 21 key features across two lighting conditions and medicine groups. When many statistical tests are conducted, the chance of observing at least one result below a chosen threshold can increase, even if there is no underlying effect for the features being tested. General statistical approaches can address this issue through adjustments, prespecified testing hierarchies, or cautious interpretation of exploratory results. The registry record does not report whether any such approach was used. The 83 analyses also cannot be assumed to correspond only to the primary endpoint; the record does not specify the mapping between analyses and outcomes.

What do confidence intervals add?

General statistical explanation: a confidence interval describes a range of effect estimates compatible with the data and the method’s assumptions. It helps readers consider precision as well as whether an estimate crosses a significance threshold. The registry record does not include confidence intervals or numerical primary-endpoint estimates, so the precision of any feature-level or group-level differences cannot be evaluated.

What does randomization contribute?

The study is listed as randomized and parallel, with two medicine groups. General statistical explanation: randomization is intended to reduce systematic differences between groups at assignment, while a parallel design assigns participants to one group rather than having every participant receive every assigned condition. Randomization does not by itself remove measurement error, missing-data concerns, or bias from unmasked measurement and analysis. The record lists masking as none and does not report the allocation method or the details of implementation. The primary endpoint’s baseline-to-peak comparison also involves measurements within participants; the record does not say how that repeated-measure structure was handled statistically.

Why consider over-dispersion?

General statistical explanation: over-dispersion occurs when observed variability is greater than a statistical model assumes. It can make standard errors too small if the model does not account for that extra variation. This matters in count outcomes and other settings where measurements vary more widely than expected under a chosen model. The primary endpoint is a count of features meeting a significance criterion, but the registry record does not describe a model for that count or indicate whether over-dispersion was assessed. It would therefore be inappropriate to assume that a particular count model was used.

How should planning calculations be read?

General statistical explanation: a sample-size calculation based on an observed effect can illustrate the group size that would be associated with specified assumptions. It is not a measure of the study’s observed power and does not show that a future or completed study had a particular probability of detecting an effect. The planning assumptions described for this analysis use a two-sided significance level of 0.05, equal allocation, a normal approximation, and fractions of an observed effect. The registry record does not report the trial’s own sample-size justification. Any planning illustration should therefore be distinguished from the original design rationale and from observed results.

What details are needed to reproduce the analysis?

General statistical explanation: readers need a clear definition of the analysis population, the method used for each endpoint, the handling of repeated observations and missing measurements, any multiplicity procedure, and the effect estimates with measures of uncertainty. The registry record identifies the FAS population for the primary endpoint, but does not report the operational definition of FAS or the detailed analysis procedures. The record also does not report whether the analysis was adjusted for covariates or how incomplete measurements were treated. Those omissions prevent independent reconstruction of the primary analysis from the registry description.

10. Multiplicity, Missing Data and Analysis Populations

The primary endpoint evaluates 21 key features and reports findings under two ambient-light conditions for each medicine. The registry record lists 83 analyses across 6 outcome measures. This creates a multiplicity question: when multiple features, outcomes, or comparisons are tested, an unadjusted significance threshold can yield findings that appear noteworthy by chance. General statistical approaches include controlling an overall error rate, controlling a false-discovery rate, or defining a prespecified testing hierarchy. The record does not report whether any of these methods was used or how the 83 analyses relate to the different outcomes.

The endpoint description states that a feature is considered changed when the difference between averages is significant at p < 0.05. It does not say whether this is an adjusted threshold or whether each feature is tested independently. The specific test, model, and any prespecified contrasts are not reported in the registry record. Consequently, the statistical meaning of a feature count cannot be fully assessed from the definition alone.

The FAS population is named for the primary endpoint, but its definition and the number of participants included in that analysis are not reported in the registry record. The record does not describe missing-data handling, exclusions, protocol deviations, or whether analyses followed assigned groups. It also does not explain how many participants posted complete measurements in each lighting condition or at each relevant measurement occasion.

These omissions matter because incomplete eye measurements could affect which features can be tested and which participants contribute to the averages. General statistical explanation: different approaches to missing data rely on different assumptions, and the resulting estimates can differ when those assumptions do not hold. Without the analysis population definition and missing-data method, the primary endpoint’s susceptibility to incomplete observations cannot be judged.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry record reports serious adverse events separately for the Cannabinoid and Phenethylamine groups. It lists zero serious adverse events in each group. For other adverse events, it reports 14 of 19 participants at risk in the Cannabinoid group and 12 of 12 at risk in the Phenethylamine group. These entries are counts of participants affected, not counts of individual event episodes.

The figures do not provide event descriptions, timing, duration, severity categories for non-serious events, or the number of events per participant. The record also does not provide a statistical comparison between groups. The at-risk counts are the denominators attached to these safety entries; the registry record does not explain how they relate to the total enrollment of 34 or whether every enrolled participant contributed to each safety summary.

Zero reported serious adverse events means that none are listed for these group entries in the record. It does not establish that no adverse events occurred: other adverse events are listed in both groups. Nor do these counts alone establish a comparative safety profile, because the group sizes, event details, and uncertainty around any between-group contrast are not presented as a formal analysis.

12. What the Result Does, and Does Not, Mean

The study asks whether mobile-phone eye measurements produce features that differ between baseline and peak plasma concentration after simulated cannabinoid or phenethylamine intake. The primary outcome is a count of features meeting a stated significance rule, assessed under dim and bright ambient light. This is a focused measurement question in healthy volunteers, not a clinical treatment comparison in people receiving care for substance use disorder.

The registry record identifies the endpoint, the 21 eye features, the two light conditions, and the p < 0.05 criterion. However, numerical primary-endpoint results are not reported in the registry record. The available description therefore does not show how many features met the criterion, the magnitude or direction of any differences, or how results varied between medicines or lighting conditions. It cannot establish measurement performance based on the outcome definition alone.

Even if a feature meets a significance threshold, that finding would not by itself establish that the change is large, clinically meaningful, reproducible, or specific to a substance. Those questions require effect estimates, uncertainty, relevant comparisons, and evidence addressing alternative explanations. The record’s listed secondary outcomes include comparisons involving refined features, clinic and home measurements, and adverse events, but their numerical findings are not reported in the registry record.

The safety entries report no serious adverse events in either group, alongside other adverse events in both groups. They are descriptive counts and do not provide enough information to compare event rates or characterize the events in detail. The record also does not report the sample-size rationale, multiplicity approach, or detailed missing-data methods.

Accordingly, the registry information supports a description of the study’s design and measurement question, but not a conclusion about whether the application accurately indicates medicine use or whether the measured features can be generalized to patients with substance use disorder. The study’s stated context is post-market follow-up in healthy volunteers, and the specific medicines used to simulate intake are not identified in the registry record.

13. Why This Trial Matters Statistically

This study raises several statistical issues that are central to interpreting digital measurement research. The primary outcome is not a single measurement value but a count of eye features that pass a significance threshold. Counts of significant features can be affected by the number of features tested, the way repeated measurements are handled, and the variability in the measurements. The registry record lists 21 features, two lighting conditions, and 83 analyses, making the prespecification and multiplicity strategy important to interpretation.

The design also separates two medicine groups and measures participants before and after intake. That structure makes it important to distinguish within-participant change from differences between groups, and to account appropriately for repeated measurements. The record reports randomization and a parallel design, but does not provide the allocation procedure or detailed analysis model. It also lists no masking, so the way measurements and analyses were protected from potential knowledge of group assignment is not described.

Measurement context is another key issue. The study collects application readings in clinic and home settings, and under 50 Lux and 500 Lux conditions. The secondary outcome descriptions indicate an interest in comparing these contexts and in refining eye features. This makes clear reporting of measurement conditions and analysis definitions important when assessing whether a device’s readings are consistent across settings.

Finally, the record’s endpoint description and safety counts are not a substitute for numerical efficacy or measurement-performance results. The primary endpoint findings are not reported in the registry record, and the safety entries do not include event details or a formal group comparison. These gaps illustrate why registry interpretation must separate a clearly stated research question from evidence about the resulting measurements.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The most important trial-specific limitation in the registry record is the absence of numerical primary-endpoint results. Although the endpoint is defined as the number of changed features and the record specifies the two lighting conditions, the observed counts and corresponding estimates are not reported in the registry record. Effect sizes, confidence intervals, and feature-level findings are also not available there.

The medicines used to simulate cannabinoid and phenethylamine intake are not named in the registry record. As a result, the exact interventions cannot be identified from the group descriptions. The study is described as involving healthy volunteers, which limits direct interpretation for patients receiving treatment for substance use disorder. The record’s listing of SUD as a condition does not change the stated participant population.

The study is unmasked, and the registry record does not describe how measurements or analyses were protected from knowledge of group assignment. The allocation method and ratio are also not reported. The endpoint involves many feature-level tests, while the record does not state whether multiplicity was addressed. The specific statistical tests, model, and handling of repeated measurements are not reported.

The primary endpoint names the FAS population, but its definition and analysis sample size are not reported. Missing-data methods, exclusions, and a participant flow accounting are also absent. The safety entries provide serious and other adverse-event counts, but do not give event descriptions or explain how the safety denominators relate to enrollment. The registry record does not report the original sample-size justification or detailed protocol-based analysis plan.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication — NCT06629740.
• Registry record last updated 2026-07-20; status last verified 2026-06.
• Results first posted 2026-07-20.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT06629740 is a completed, randomized, unmasked, parallel-group post-market follow-up study sponsored by Kontigo Care AB. Enrollment is listed as 34. The study involved healthy volunteers using a mobile phone application to measure eye characteristics before and after a single administration of a selected medicine in the Cannabinoid or Phenethylamine group. The specific medicines are not named in the registry record.

The primary endpoint counts native eye features that differ between baseline and LC-MS/MS-verified peak plasma concentration, using p < 0.05 as the criterion for a changed feature. The outcome is described for 21 features and for measurements in 50 Lux and 500 Lux conditions. The primary population is listed as FAS, but numerical endpoint results are not reported in the registry record.

The safety entries list zero serious adverse events in each group and report other adverse events for 14 of 19 participants at risk in the Cannabinoid group and 12 of 12 at risk in the Phenethylamine group. The record does not provide event-level details or a formal comparison between groups.