Trial Outcomes & Findings for A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication (NCT NCT06629740)

First subject in was on 01Nov2024, and last subject out was on 18Mar2025. Subjects were identified through advertisement and healthy volunteer database available at site.

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.

Race and Ethnicity were not collected from any participant.

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.

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.

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).

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.

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.

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