Effects of mobile phone-related distraction on driving performance at roundabouts: Eye movements tracking perspective.

Modern road infrastructures are complex networks featuring various elements such as roads, bridges, intersections, and roundabouts, with advanced control systems. Roundabouts have gained prominence as a safer alternative to traditional intersections promoting smoother traffic flow and fewer collisions by guiding traffic in one direction, encouraging reduced speed, and minimizing conflict points.This study investigated driver behavior within roundabouts, focusing on gaze behavior, particularly the left-side mirror and window, under mobile phone distraction conditions. In addition, the effects of roundabout specifications (i.e., number of lanes and size of the central island) and the drivers' characteristics (i.e., driving experience) were examined.In total, 43 participants, aged 19-56 years including 30 males and 13 females, held a valid driving license, drove through a virtual simulated urban road containing four roundabouts, implemented in a static driving simulator, under baseline condition (no distraction) as well as mobile-induced distraction. Driving simulator data were collected and drivers' gaze direction and fixation on nine areas of interest were captured with an eye tracker. Results: showed that experienced drivers exhibit a more fixation on the left-side mirror and window and were less distracted. Moreover, the road environment, i.e., the number of cars and the roundabout size, significantly influenced the drivers' attention. As regards the driving performance, the number of infractions increased when the drivers diverted focus from the left side of the car. The outcomes of the present study might help to improve traffic safety at roundabouts.

Risk assessment of driver performance in the oil and gas transportation industry: Analyzing the relationship between driver vigilance, attention, reaction time, and safe driving practices.

The increasing use of road traffic for land transportation has resulted in numerous road accidents and casualties, including those involving oil and gas tanker vehicles. Despite this, little empirical research has been conducted on the factors influencing tanker drivers' performance. This study aims to address this knowledge gap, particularly in the energy transportation industry, by examining the driving performance factors that affect tanker drivers and incorporating risk assessment measures. The model variables were identified from the literature and used to develop a survey questionnaire for the study. A total of 307 surveys were collected from Malaysian oil and gas tanker drivers, and the driving performance factors were contextually adjusted using the Exploratory Factor Analysis (EFA) approach. The driving performance model was developed using partial least squares structural equation modeling (PLS-SEM). The EFA results categorized driving performance into two constructs: 1) drivers' reaction time with ß = 0.320 and 2) attention and vigilance with ß value = 0.749. The proposed model provided full insight into how drivers' reaction time, attention, and vigilance impact drivers' performance in this sector, which can help identify potential risks and prevent accidents. The findings are significant in understanding the factors that affect oil and gas drivers' performance and can aid in enhancing oil and gas transportation management by including effective risk assessment measures to prevent fatal crashes.

R2DRV: study protocol for longitudinal assessment of driving after mild TBI in young drivers.

BACKGROUND: Mild traumatic brain injury (mTBI) and traffic-related injuries are two major public health problems disproportionately affecting young people. Young drivers, whose driving skills are still developing, are particularly vulnerable to impaired driving due to brain injuries. Despite this, there is a paucity of research on how mTBI impacts driving and when it is safe to return to drive after an mTBI. This paper describes the protocol of the study, R2DRV, Longitudinal Assessment of Driving After Mild TBI in Young Drivers, which examines the trajectory of simulated driving performance and self-reported driving behaviors from acutely post-injury to symptom resolution among young drivers with mTBI compared to matched healthy drivers. Additionally, this study investigates the associations of acute post-injury neurocognitive function and cognitive load with driving among young drivers with and without mTBI. METHODS: A total of 200 young drivers (ages 16 to 24) are enrolled from two study sites, including 100 (50 per site) with a physician-confirmed isolated mTBI, along with 100 (50 per site) healthy drivers without a history of TBI matched 1:1 for age, sex, driving experience, and athlete status. The study assesses primary driving outcomes using two approaches: (1) high-fidelity driving simulators to evaluate driving performance across four experimental study conditions at multiple time points (within 96 h of injury and weekly until symptom resolution or 8 weeks post-injury); (2) daily self-report surveys on real-world driving behaviors completed by all participants. DISCUSSION: This study will fill critical knowledge gaps by longitudinally assessing driving performance and behaviors in young drivers with mTBI, as compared to matched healthy drivers, from acutely post-injury to symptom resolution. The research strategy enables evaluating how increased cognitive load may exacerbate the effects of mTBI on driving, and how post-mTBI neurocognitive deficits may impact the driving ability of young drivers. Findings will be shared through scientific conferences, peer-reviewed journals, and media outreach to care providers and the public.

The effect of breathing hypoxic gas (15% FIO2 ) on physiological and behavioral outcomes during simulated driving in healthy subjects.

Hypoxia is mainly caused by cardiopulmonary disease or high-altitude exposure. We used a driving simulator to investigate whether breathing hypoxic gas influences driving behaviors in healthy subjects. Fifty-two healthy subjects were recruited in this study, approved by the Science and Engineering Ethical Committee. During simulated driving experiments, driving behaviors, breathing frequency, oxygen saturation (SpO2 ), and heart rate variability (HRV) were analyzed. Each subject had four driving sessions; a 10-min practice and three 20-min randomized interventions: normoxic room air (21% FIO2 ) and medical air (21% FIO2 ) and hypoxic air (equal to 15% FIO2 ), analyzed by repeated measures ANOVA. Driving behaviors and HRV frequency domains showed no significant change. Heart rate (HR; p < 0.0001), standard deviation of the RR interval (SDRR; p = 0.03), short-term HRV (SD1; p < 0.0001), breathing rate (p = 0.01), and SpO2 (p < 0.0001) were all significantly different over the three gas interventions. Pairwise comparisons showed HR increased during hypoxic gas exposure compared to both normoxic interventions, while SDRR, SD1, breathing rate, and SpO2 were lower. Breathing hypoxic gas (15% FiO2 , equivalent to 2710 m altitude) may not have a significant impact on driving behavior in healthy subjects. Furthermore, HRV was negatively affected by hypoxic gas exposure while driving suggesting further research to investigate the impact of breathing hypoxic gas on driving performance for patients with autonomic dysfunction.

Residual effects of medications for sleep disorders on driving performance: A systematic review and network meta-analysis of randomized controlled trials: NMA driving and hypnotics.

Sleep medications often carry residual effects potentially affecting driving safety, warranting network meta-analysis (NMA). PubMed/EMBASE/TRID/Clinicaltrials.gov/WHO-ICTRP/WebOfScience were inquired for randomized controlled trials of hypnotic driving studies in persons with insomnia and healthy subjects up to 05/28/2023, considering the vehicle's standard deviation of lateral position - SDLP (Standardized Mean Difference/SMD) and driving impairment rates on the first morning (co-primary outcomes) and endpoint. Risk-of-bias, global/local inconsistencies were measured, and CINeMA was used to assess the confidence in the evidence. Of 4,805 identified records, 26 cross-over RCTs were included in the systematic review, of which 22 entered the NMA, focusing on healthy subjects only. After a single administration, most molecules paralleled the placebo, outperforming zopiclone regarding SDLP. In contrast, ramelteon 8 mg, daridorexant 100 mg, zolpidem 10 mg bedtime, zolpidem middle-of-the-night 10 mg and 20 mg, mirtazapine 15-30 mg, and triazolam 0.5 mg performed significantly worse than placebo. Lemborexant 2.5-5 mg, suvorexant 15-20 mg, and zolpidem 3.5 mg middle-of-the-night associated with lower impairment than zopiclone. Repeated administration (maximum follow-up time of ten days) caused fewer residual effects than acute ones, except for flurazepam. Heterogeneity and inconsistency were negligible. Confidence in the evidence was low/very low. Sensitivity analyses confirmed the main analyses. Most FDA-approved hypnotics overlapped placebo at in-label doses, outperforming zopiclone. Repeated administration for 15 days or less reduced residual effects, warranting further research on the matter.

A Randomized, Phase 3, Double-Blind, Crossover Comparison of Multilayer, Extended-Release Methylphenidate (PRC-063), and Lisdexamfetamine in the Driving Performance of Young Adults With ADHD.

OBJECTIVE: To compare PRC-063 (multilayer-release methylphenidate) and lisdexamfetamine dimesylate (LDX) on the driving performance of young adults with attention deficit hyperactivity disorder (ADHD) in a randomized, double-blind, crossover study. METHOD: Following up to 21 days of each treatment in each treatment course (PRC-063/LDX or LDX/PRC-063), subjects completed a 15-hour driving simulator laboratory assessment. The primary outcome measure was the Tactical Driving Quotient (TDQ) and the Clinical Global Impressions-Improvement (CGI-I) scale was a secondary outcome measure. RESULTS: Forty-four subjects completed the study. PRC-063 and LDX had equivalent effects on driving performance through a 15-hour time period (least square mean difference -0.3 [standard error 1.08], 95% confidence interval [-2.4, 1.8], p = .793). Consistent improvement in CGI-I was observed. The incidence of treatment-emergent adverse events was similar for each treatment sequence. CONCLUSIONS: PRC-063 and LDX had comparable effects on driving performance, from 1 through 15 hours, the last time point measured.

A semi-naturalistic open-label study examining the effect of prescribed medical cannabis use on simulated driving performance.

BACKGROUND: Despite increasing medical cannabis use, research has yet to establish whether and to what extent products containing delta-9-tetrahydrocannabinol (THC) impact driving performance among patients. Stable doses of prescribed cannabinoid products during long-term treatment may alleviate clinical symptoms affecting cognitive and psychomotor performance. AIM: To examine the effects of open-label prescribed medical cannabis use on simulated driving performance among patients. METHODS: In a semi-naturalistic laboratory study, 40 adults (55% male) aged between 23 and 80 years, consumed their own prescribed medical cannabis product. Driving performance outcomes including standard deviation of lateral position (SDLP), the standard deviation of speed (SDS), mean speed and steering variability were evaluated using the Forum8 driving simulator at baseline (pre-dosing), 2.5 h and 5 -h (post-dosing). Perceived driving effort (PDE) was self-reported after each drive. Oral fluid and whole blood samples were collected at multiple timepoints and analysed for THC via liquid chromatography-mass spectrometry. RESULTS: A significant main effect of time was observed for mean speed (p = 0.014) and PDE (p = 0.020), with patients displaying modest stabilisation of vehicle control, increased adherence to speed limits and reductions in PDE post-dosing, relative to baseline. SDLP (p = 0.015) and PDE (p = 0.043) were elevated for those who consumed oil relative to flower-based products. Detectable THC concentrations were observed in oral fluid at 6-h post-dosing (range = 0-24 ng/mL). CONCLUSIONS: This semi-naturalistic study suggests that the consumption of medical cannabis containing THC (1.13-39.18 mg/dose) has a negligible impact on driving performance when used as prescribed.

Modulating Driver Alertness via Ambient Olfactory Stimulation: A Wearable Electroencephalography Study.

Poor alertness levels and related changes in cognitive efficiency are common when performing monotonous tasks such as extended driving. Recent studies have investigated driver alertness decrement and possible strategies for modulating alertness with the goal of improving reaction times to safety critical events. However, most studies rely on subjective measures in assessing alertness changes, while the use of olfactory stimuli, which are known to be strong modulators of cognitive states, has not been commensurately explored in driving alertness settings. To address this gap, in the present study we investigated the effectiveness of olfactory stimuli in modulating the alertness state of drivers and explored the utility of electroencephalography (EEG) in developing objective brain-based tools for assessing the resulting changes in cortical activity. Olfactory stimulation induced a significant differential effect on braking reaction time. The corresponding effect to the cortical activity was characterized using EEG-derived metrics and the devised machine learning framework yielded a high discriminating accuracy (92.1%). Furthermore, neural activity in the alpha frequency band was found to be significantly associated with the observed drivers' behavioral changes. Overall, our results demonstrate the potential of olfactory stimuli to modulate the alertness state and the efficiency of EEG in objectively assessing the resulting cognitive changes.

Investigating the impact of HMI on drivers' merging performance in intelligent connected vehicle environment.

Intelligent Connected Vehicle (ICV) is considered one of the most promising active safety technologies to address current transportation challenges. Human-Machine Interface (HMI) plays a vital role in enhancing user driving experience with ICV technology. However, in an ICV environment, drivers may exhibit excessive reliance on HMI, resulting in diminished proactive observation and analysis of the road environment, and subsequently leading to a potential decrease in drivers' situational awareness. This reduced situational awareness may consequently lead to a decline in their overall engagement in driving tasks. Therefore, to comprehensively investigate the impact of HMI on driver performance in various ICV environments, this study incorporates three distinct HMI systems: Control group, Warning group, and Guidance group. The Control group provides basic information, the Warning group adds front vehicle icon and real-time headway information, while the Guidance group further includes speed and voice guidance features. Additionally, the study considers three types of mainline vehicle gaps, namely, 30 m, 20 m, and 15 m. Through our self-developed ICV testing platform, we conducted driving simulation experiments on 43 participants in a freeway interchange merging area. The findings reveal that, drivers in the Guidance group exhibited explicit acceleration while driving on the ramp. Drivers in the Guidance and Warning groups demonstrated smoother speed change trends and lower mean longitudinal acceleration upon entering the acceleration lane compared to the Control group, indicating a preference for more cautious driving strategies. During the pre-merging section, drivers in the Warning group demonstrated a more cautious and smooth longitudinal acceleration. The Guidance group's HMI system assisted drivers in better speed control during the post-merging section. Differences in mainline vehicle gaps did not significantly impact the merging positions of participants across the three HMI groups. Drivers in the Guidance group merged closest to the left side of the taper section, while the Control group merged farthest. The research findings offer valuable insights for developing dynamic human-machine interfaces tailored to specific driving scenarios in the environment of ICVs. Future research should investigate the effects of various HMIs on driver safety, workload, energy efficiency, and overall driving experience. Conducting real-world tests will further validate the findings obtained from driving simulators.

A Comparison of Night Hazard Detection between Younger and Older Drivers under Driving Simulation and Real-World Conditions.

''Using eye-tracking technology, this study examined hazard detection at night. Using a 2 (younger versus older) x 2 (simulator versus on road) repeated-measures mixed design, 16 older adults and 17 younger adults drove their own vehicle and on a driving simulator under nighttime conditions wearing eye tracking technology. Both driving conditions had three roadway hazards of pedestrians looking at their cell phone while posed to cross the roadway. Pupil glances were recorded using outcome measures of total fixation duration, number of fixations, and time to first fixation. Results showed older adults detected hazards similarly to younger adults, especially during on-road performance. Night hazard detection was similar across driving conditions except for time to first fixation, which was faster on-road for both age groups. Results support potential use of driving simulators as a proxy for on-road with night driving needed for research and practice.

Potential risk of driving performance under combined conditions of taking second-generation antihistamines and attending calls using a hands-free function.

OBJECTIVE: Although second-generation antihistamines have reduced sedation-related side effects compared to first-generation antihistamines, sedation may still impair motor vehicle driving performance. Moreover, receiving/making phone calls using a hands-free function can negatively affect driving performance. Therefore, herein, driving performance was evaluated using a driving simulator to gain insights into the hazards of driving by combining second-generation antihistamines and a calling task, i.e., simulated calls using a hands-free function. METHODS: In this study, 20 subjects drove in a driving simulator in the absence or presence of a calling task while taking or not taking second-generation antihistamines. Driving performances for nonemergency and emergency events were determined, and a comparative analysis of intra-individual variability when taking and not taking second-generation antihistamines was conducted. RESULTS: First, when nonemergency and emergency were examined in the absence of a calling task, no significant difference in driving performance was observed between taking and not taking second-generation antihistamines. Next, when the nonemergency event was examined in the presence of a calling task, no significant difference in driving performance was observed between taking and not taking second-generation antihistamines. However, when the emergency event was examined in the presence of a calling task, a significant difference in driving performance was observed between taking and not taking second-generation antihistamines, thus resulting in reduced driving performance. CONCLUSIONS: The new system with added calling tasks allowed the extraction of the potential risks of driving performance of second-generation antihistamines that may have been previously overlooked. This study suggests that pharmacists and other healthcare professionals may need to instruct people taking any second-generation antihistamine to focus on driving and not on subtasks that require cognitive load such as talking while driving.

Post Take-Over Performance Varies in Drivers of Automated and Connected Vehicle Technology in Near-Miss Scenarios.

OBJECTIVE: This study examined the impact of monitoring instructions when using an automated driving system (ADS) and road obstructions on post take-over performance in near-miss scenarios. BACKGROUND: Past research indicates partial ADS reduces the driver's situation awareness and degrades post take-over performance. Connected vehicle technology may alert drivers to impending hazards in time to safely avoid near-miss events. METHOD: Forty-eight licensed drivers using ADS were randomly assigned to either the active driving or passive driving condition. Participants navigated eight scenarios with or without a visual obstruction in a distributed driving simulator. The experimenter drove the other simulated vehicle to manually cause near-miss events. Participants' mean longitudinal velocity, standard deviation of longitudinal velocity, and mean longitudinal acceleration were measured. RESULTS: Participants in passive ADS group showed greater, and more variable, deceleration rates than those in the active ADS group. Despite a reliable audiovisual warning, participants failed to slow down in the red-light running scenario when the conflict vehicle was occluded. Participant's trust in the automated driving system did not vary between the beginning and end of the experiment. CONCLUSION: Drivers interacting with ADS in a passive manner may continue to show increased and more variable deceleration rates in near-miss scenarios even with reliable connected vehicle technology. Future research may focus on interactive effects of automated and connected driving technologies on drivers' ability to anticipate and safely navigate near-miss scenarios. APPLICATION: Designers of automated and connected vehicle technologies may consider different timing and types of cues to inform the drivers of imminent hazard in high-risk scenarios for near-miss events.

Driving-related cognitive skills during antidepressant transcranial direct current stimulation: results in a subsample from the DepressionDC trial.

Therapeutic transcranial direct current stimulation (tDCS) is a well-tolerated neuromodulatory intervention. However, there are currently no data on its impact on driving skills. Therefore, we conducted a validated assessment of driving-related cognitive skills in participants of the DepressionDC trial, a multicenter, randomized-controlled trial investigating the antidepressant effects of 6-week prefrontal tDCS in patients with major depressive disorder (MDD). Twenty-one patients (12 women, active tDCS, n = 11, sham, n = 10) underwent an assessment of driving-related cognitive skills before and after the intervention. Using a Bayesian analysis approach, we found no group differences between active tDCS and sham tDCS in the pre-post treatment changes for visual perception (estimated median difference: 3.41 [-3.17, 10.55 89%-CI], BF01: 2.1), stress tolerance (estimated median difference: 0.77 [-2.40, 4.15 89%-CI], BF01: 1.6), and reaction time (estimated median difference: 2.06 [-12.33, 16.83 89%-CI], BF01: 6.5). Our results indicate that repeated sessions of a conventional bifrontal tDCS protocol do not negatively impact driving-related cognitive skills in patients with MDD.

Driving safety: Investigating the cognitive foundations of accident prevention.

Driving is a crucial aspect of personal independence, and accurate assessment of driving skills is vital for ensuring road safety. This study aimed to identify reliable cognitive predictors of safe driving through a driving simulator experiment. We assessed the driving performance of 66 university students in two distinct simulated driving conditions and evaluated their cognitive skills in decision-making, attention, memory, reasoning, perception, and coordination. Multiple regression analyses were conducted to determine the most reliable cognitive predictor of driving outcome. Results revealed that under favorable driving conditions characterized by good weather and limited interactions with other road users, none of the variables tested in the study were able to predict driving performance. However, in a more challenging scenario with adverse weather conditions and heavier traffic, cognitive assessment scores demonstrated significant predictive power for the rate of traffic infractions committed. Specifically, cognitive skills related to memory and coordination were found to be most predictive. This study underscores the significance of cognitive ability, particularly memory, in ensuring safe driving performance. Incorporating cognitive evaluations in driver licensing and education/training programs can enhance the evaluation of drivers' competence and promote safer driving practices.

Influence of distracted driving of online car-hailing drivers on overall driving performance.

The distraction affects driving performance and induces serious safety issues. To better understand distracted driving, this study examines the influence of distracted driving on overall driving performance. This paper analyzes the distraction behavior (mobile phone use, entertainment activities, and passenger interference) under three driving tasks. The statistical results show that viewing or sending messages is common during driving. Smoking, phone calls, and talking to passengers are evident in cruising, ride request and drop-off, respectively. Then, overall driving performance is proposed based on velocity, longitudinal acceleration (longacc) and yaw_rate. It is divided into three categories, high, medium, and low, by k-means algorithms. The average speed increases from low to high performance; however, the longacc and yaw_rate decrease. Finally, the influence of distracted driving on overall driving performance is analyzed using C4.5 algorithm. The result shows that when time is peak, the probability of high performance (HP) is higher than off-peak. The possibility of HP increases with the increase of duration; the number of, talking to passengers, listening to music or radio, eating; the duration of, viewing or sending messages, phone calls; but reduces with the increase of the number of phone calls. These findings provide theoretical support for driving performance evaluation.

Implementation of a psychomotor vigilance test to investigate the effects of driving fatigue on oil and gas truck drivers' performance.

Introduction: Driving fatigue has been shown to increase the risk of accidents and potentially fatal crashes. Fatigue is a serious risk that some drivers do not take seriously. Previous studies investigated the effects of driving fatigue in the Malaysian oil and gas transportation industry by employing survey questionnaires. However, they did not explain the behavior of fatigue. Besides, these results required validation by a more reliable method that can describe how fatigue occurs. Methods: Thus, in this study, we used the Psychomotor Vigilance Test (PVT-192) and a short survey to address driving fatigue behavior and identify the influences of driving fatigue on driving performance in real life (on the road) with actual oil and gas tanker drivers. The total participants in the experimental study were 58 drivers. Results: For the analysis, a Wilcoxon Signed Ranks Test, Z value and Spearman's rho were used to measure the significant difference between the pre and post-tests of PVT and the correlation between the fatigue variables and driving performance. Discussion: During the experiment's first and second days, this study's results indicated that driving fatigue gradually escalated. Likewise, there was a negative correlation based on the test of the relationship between the PVT data and the driving performance survey data. Additionally, the drivers suffer from accumulative fatigue, which requires more effort from the transportation company management to promote the drivers awareness of fatigue consequences.

Executive Functioning as a Predictor of Adverse Driving Outcomes in Teen Drivers With ADHD.

OBJECTIVE: The present study examined the association between executive functioning (EF) and risky driving behaviors in teens with ADHD. METHOD: Teens diagnosed with ADHD (n = 179; Mage = 17.4 years) completed two 15-min drives in a fixed-base driving simulator. EF was assessed using parent- and self-report Behavior Rating Inventory of Executive Functioning (BRIEF-2), a temporal reproduction task, and a Go/No-Go task (GNG). Driving outcomes included known predictors of crashes: count of long (>2 s) off-road glances, standard deviation (SD) of lane position (SDLP), mean speed, and SD speed. Generalized linear mixed models, controlling for intelligence and driving experience, were conducted. RESULTS: Higher rates of GNG commission errors predicted higher rates of long off-road glances. Lower parent-rated EF and increased rates of GNG omission errors predicted SDLP. Higher rates of GNG commission errors also predicted faster average driving speed. CONCLUSION: Heterogeneity in EF is associated with differences in teen ADHD risky driving behaviors.

Individual differences, ADHD diagnosis, and driving performance: effects of traffic density and distraction type.

The present study examined the impact of individual differences, attention, and memory deficits on distracted driving. Drivers with ADHD are more susceptible to distraction which results in more frequent collisions, violations, and licence suspensions. Consequently, the present investigation had 36 participants complete preliminary questionnaires, memory tasks, workload indices, and four, 4-min simulated driving scenarios to evaluate such impact. It was hypothesised ADHD diagnosis, type of cellular distraction, and traffic density would each differentially and substantively impact driving performance. Results indicated traffic density and distraction type significantly affected the objective driving facets measured, as well as subjective and secondary task performance. ADHD diagnosis directly impacted secondary task performance. Results further showed significant interactions between distraction type and traffic density on both brake pressure and steering wheel angle negatively impacting lateral and horizontal vehicle control. Altogether, these findings provide substantial empirical evidence for the deleterious effect of cellphone use on driving performance.Practitioner summary: This study examined how ADHD diagnosis, traffic density, and distraction type affect driver behaviour. Participants completed driving behaviour questionnaires, memory tasks, workload indices, and driving scenarios. Results showed that ADHD diagnosis impacted secondary task performance, while traffic and distractions significantly impacted driving performance as well secondary task performance and workload.

Unexpected vision performance with photochromic contact lenses in normal and low light conditions: An analysis of two randomized trials / Rendimiento visual inesperado con lentes de contacto fotocromáticos en condiciones normales y de poca luz: un análisis de dos ensayos aleatorios

Purpose: Evaluate the performance of a photochromic contact lens in various lighting conditions throughout the day, including those indoor and outdoor environments where the photochromic contact lens is in a less active or inactive state. Methods: Data from two clinical trials of a photochromic contact lens were analyzed to evaluate its performance in various light environments. Both studies involved a photochromic test lens (ACUVUE® OASYS with Transitions™ Light Intelligent Technology™) and a similar non-photochromic control lens (ACUVUE® OASYS 2-week with HYDRACLEAR® PLUS). The studies were both multi-visit, multi-site, 2-treatment by 3-period randomized crossover (i.e., Test/Control/Control or Control/Test/Test) dispensing studies, with follow-up visits after each 2-week dispensing period. Results: A total of 250 subjects were dispensed lenses across both studies, of which 237 total subjects completed. In situations where exposure to an activating light source is common (e.g., outdoors), the Test lens was preferred nearly 6:1 over the control lens. In situations where exposure to an activating light source is less common – indoors, driving at night, using digital devices –, the Test lens was still preferred over the control lens by margins of 4:1, nearly 4:1, and over 3:1 respectively. The Test lens was superior with respect to quality of vision, ability to see comfortably, clarity of vision, reduction of squinting while using computers and reduction of bright light while driving at night. Conclusion: The photochromic test contact lens was rated superior to a non-photochromic control lens in environmental situations where the lens is in a less active or inactive state.(AU)

Effect of CannEpil® on simulated driving performance and co-monitoring of ocular activity: A randomised controlled trial.

BACKGROUND: Medicinal cannabis products containing Δ9-tetrahydrocannabinol (THC) are increasingly accessible. Yet, policy guidelines regarding fitness to drive are lacking, and cannabinoid-specific indexations of impairment are underdeveloped. AIMS: To determine the impact of a standardised 1 mL sublingual dose of CannEpil®, a medicinal cannabis oil containing 100 mg cannabidiol (CBD) and 5 mg THC on simulated driving performance, relative to placebo and whether variations in vehicle control can be indexed by ocular activity. METHODS: A double-blind, within-subjects, randomised, placebo-controlled, crossover trial assessed 31 healthy fully licensed drivers (15 male, 16 female) aged between 21 and 58 years (M = 38.0, SD = 10.78). Standard deviation of lateral position (SDLP), standard deviation of speed (SDS) and steering variability were assessed over time and as a function of treatment during a 40 min simulated drive, with oculomotor parameters assessed simultaneously. Oral fluid and plasma were collected at 30 min and 2.5 h. RESULTS: CannEpil did not significantly alter SDLP across the full drive, although increased SDLP was observed between 20 and 30 min (p < 0.05). CannEpil increased SDS across the full drive (p < 0.05), with variance greatest at 20-30 min (p < 0.001). CannEpil increased fixation duration (p < 0.05), blink rate (trend p = 0.051) and decreased blink duration (p < 0.001) during driving. No significant correlations were observed between biological matrices and performance outcomes. CONCLUSIONS: CannEpil impairs select aspects of vehicle control (speed and weaving) over time. Alterations to ocular behaviour suggest that eye tracking may assist in determining cannabis-related driver impairment or intoxication. Australian and New Zealand Clinician Trials Registry, https://anzctr.org.au(ACTRN12619000932167).