Primary Outcome: VAS Pain Assessment
failure of the ePRO device, pain
Both primary efficacy endpoints met the prespecified statistical significance threshold. The mean difference in VAS pain severity scores between SAF312- and vehicle-treated eyes was −11.13 (SAF312 2.5% four times daily lowered VAS pain scores versus vehicle (placebo) consistently starting at 1 hour after dosing and during the first 30 hours after PRK. Both primary endpoints (VAS pain at 6 hours and over 0–12 hours) were met. VAS data from the first 10 participants were not evaluable due to failure of the ePRO device. Plotted means are least squares means from the primary efficacy analysis of VAS using a mixed-model repeated measures approach. Any recorded VAS pain score at time points within 4 hours after ORM use was replaced by the VAS record taken immediately before ORM use. **Statistically significant at α = 0.10. 