Pupil dilation evaluation of two mydriatic dosing profiles delivered by the Optejet

To compare pupil dilation achieved by a single microdose versus two microdoses of tropicamide-phenylephrine fixed combination (TR-PH FC) delivered by the Optejet . In this assessor-masked, crossover, noninferiority study, 60 volunteers underwent two treatment visits and received either one (∼8 μl) or two sprays (∼16 μl) of TR-PH FC to both eyes in randomly assigned order. At 35 min postdose, mean change in pupil diameter was 4.6 mm and 4.9 mm following one or two sprays, respectively. The estimated treatment group difference was -0.249 mm (standard error: 0.036; 95% CI: -0.320, -0.177). No adverse events were reported. A single microdose was noninferior to two microdoses of TR-PH FC and achieved clinically significant mydriasis in a timely manner. Clinical Trial Registration: ( ) Pupil dilation efficacy and efficiency were evaluated using microdosing via the Optejet . The Optejet is a new ophthalmologic drug device that utilizes piezoelectric technology to deliver a fine, controlled, horizontal microdroplet spray with precise volume (∼8 μl), spray pattern and velocity. A single spray versus two sprays of tropicamide-phenylephrine fixed combination (TR-PH FC) were administered to both eyes anesthetic free. Efficacy and safety were evaluated at specific time intervals. The primary end point was the mean change in pupil diameter at 35 min compared with baseline. At 35 min, clinically relevant dilation was observed, with a mean change of 4.55 mm ± 0.68 for one spray and 4.88 ± 0.60 for two sprays. The treatment group difference of one spray of TR-PH FC was noninferior to two sprays (p