Study Design and Treatment
This phase 2, participant- and investigator-masked, randomized, placebo (vehicle)–controlled study (NCT02961062) was conducted across four centers in the United States from 2016 to 2018. The study was approved by the institutional review boards of all clinical sites and adhered to the tenets of the Declaration of Helsinki. Written informed consent was obtained from all participants.The study used a bilateral crossover designStudy design: phase 2, randomized, masked, crossover trial. *As a result of the crossover design, each participant served as their own control (one eye treated with SAF312 and the other eye treated with vehicle). PRK surgery was first performed in the participant's nondominant eye, as determined at screening and agreed upon by the participant and the investigator. Site staff administered the first study dose inside the operating room at the conclusion of the surgery, and subsequent doses were self-administered. The participant returned for follow-up visits on days 2, 3, 4, and 8 of period 1 after surgery in the first eye, with optional daily visits to monitor the participant until wound healing was complete. The second eye surgery (dominant eye) was performed in period 2 (after the resolution of the epithelial defect in the first eye). After the second surgery (period 2), participants received opposing study drug treatment for 72 hours at same dosing schedules and follow-up visits as in period 1. BL, baseline; D, day; 