Safety Assessment
nasopharyngitis, vomiting, tinnitus, pyrexia, haze, headache, deaths, oropharyngeal pain, arthralgia
CORNEAL INFILTRATE, KERATITIS IN BOTH EYES, OPACITY, CORNEA, NASOPHARYNGITIS, TINNITUS
All participants completed the study; there were no drug or study discontinuations due to AEs in the study, and no SAEs or deaths were reported. The determination of whether an AE was drug related or not was up to the investigators’ discretion. Moreover, it was determined based on whether the AE was consistent with those AEs typically seen and expected with the PRK procedure. A total of 10 patients (25%) experienced at least one treatment-emergent AE. Due to the crossover design, some patients accounted for the AEs in both SAF312 and vehicle treatment groups. Eight patients experienced AEs during treatment with SAF312, and five patients experienced AEs during treatment with vehicle. With SAF312 and vehicle treatments, 8 of 40 and 5 of 40 participants had at least one AE, respectively (Overall Incidence of AEsNonocular AEs and mild severity AEs were reported in one participant prior to drug (after signing the informed consent and before administration of any study drug). An AE starting in one period and continuing into the next period was counted only in the onset period. Due to the crossover design, some patients accounted for the AEs in both SAF312 and vehicle treatment groups.Incidence of AE by Preferred TermAn AE starting in one period and continuing into the next was counted only in the onset period. One participant reported mild headache prior to drug. No deaths or serious AEs were reported. Of the 40 participants in this study, 8 and 5 had AEs while on SAF312 and vehicle, respectively. Due to the crossover design, some patients accounted for the AEs in both SAF312 and vehicle treatment groups.No drug, or baseline-emergent AE: AEs encountered after signaling the informed consent and before the administration of any study drug (SAF312 or vehicle).A small corneal infiltrate ≤0.5 mm in superior cornea near limbus on postoperative day 5 that resolved after 7 days was reported in one participant.Corneal opacity (haze) in both eyes at the end-of-study visit 36 days after last dose was reported in one participant.Punctate keratitis in both eyes was reported in one participant, both on postoperative day 8, that had resolved at the next visit (∼3 months postoperatively).One participant had tinnitus during vehicle treatment, had transient arthralgia on day 3 of SAF312 treatment, and developed a common cold with nasopharyngitis and oropharyngeal pain 13 days after the last dose of SAF312.One participant developed pyrexia and vomiting at the same time 36 days after the study medication, which was SAF312.