Statistical Analyses
pain
SECONDARY
This study was powered based on the difference in mean 6-hour VAS score because there were insufficient data to calculate an exact sample size for the second coprimary endpoint of average VAS from 0 to 12 hours. Further, with a prespecified false-positive rate (α) for all tests of 0.10, a VAS pain assessments were analyzed 6 hours postoperatively using a linear mixed model for repeated measures, which accounted for the crossover nature of the trial. VAS pain assessment up to 12 hours postoperatively was assessed with a mixed-effect model accounting for the crossover effect for average (0–12 hours) VAS. The difference in least squares mean VAS scores between SAF312-treated eyes and vehicle-treated eyes, the 90% confidence interval, and To assess the secondary endpoint of oral rescue medication use, McNemar's test was used to analyze the difference between the number of participants who did not take oral analgesics between SAF312 and vehicle treatment during the intervals of interest (0–6, 0–12, 0–24, 0–48, and 0–72 hours postoperatively); the associated 