About the Trial
Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis (NCT04024891)
Randomized, 2-arm cross-over, double-masked Phase 2b study in approximately 32 healthy subjects, evaluating safety and efficacy of Nyxol in subjects with pharmacologically induced mydriasis.
At the first visit, subjects were screened for study eligibility.
After screening, eligible subjects were randomized 1:1 to one of the two treatment sequences:
Treatment sequence 1: Placebo (Visit 1), Nyxol (Visit 2).
Treatment sequence 2: Nyxol (Visit 1), Placebo (Visit 2).
Randomization was stratified by mydriatic agent (2.5% phenylephrine or 1% tropicamide). Approximately one half of the randomized subjects received 2.5% phenylephrine and one half received 1% tropicamide. Subjects received their mydriatic agent 1 hour before treatment. Each subject received the same mydriatic agent throughout the study.
At each visit, pupil diameter (PD), accommodation, near and distance visual acuity (VA) and redness in each eye was measured before (-1 hour/baseline) and 1 hour after (maximum/0 minutes) the mydriatic agent instillation in each eye (i.e., right before the study treatment is administered), and at 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after treatment dosing. As needed, two hours post treatment, subjects were permitted to request the administration of Lumify® in the non-study eye.