Secondary efficacy endpoints
INTRAOCULAR PRESSURE, PGA
The analysis for the primary efficacy endpoint was repeated on the PP population; the threshold for clinical non-inferiority was met at eight out of nine time points. Non-inferiority could not be confirmed overall for this population, because the upper bound 95% CI was 1.55 at the Week 6 08:00 time point. The mean IOP change at each of the pre-specified time points demonstrated clinical non-inferiority of NET/LAT relative to BIM/TIM using observed values (Fig. Actual mean IOP change at the pre-specified timepoints. *p < 0.005. Analysis performed in ITT set. FDC, fixed-dose combination; IOP, intraocular pressure; ITT, intention-to-treat; SD, standard deviationPercentage of patients reaching pre-specified categorical treatment targets at Month 3: mean diurnal IOP (mmHg). Analysis performed in ITT set. Baseline diurnal mean IOP: NET/LAT, 25.05 mmHg (SD ± 3.405); BIM/TIM, 24.81 mmHg (SD ± 3.256). N, number of patients randomized; n, number of patients with data included at this time point; FDC, fixed-dose combination; IOP, intraocular pressure; ITT, intention-to-treatPercentage of patients reaching pre-specified categorical treatment targets at Month 3: percentage reduction from baseline in mean diurnal IOP. Analysis performed in ITT set. N, number of patients randomized; n, number of patients with data included at this time point. FDC, fixed-dose combination; IOP, intraocular pressure; ITT, intention-to-treatThe range of mean diurnal IOPs during the study period was 15.4 to 15.6 mmHg and 15.2 to 15.6 mmHg in the NET/LAT and BIM/TIM groups, respectively; no statistically significant differences were observed in the ITT analysis population. Mean change from diurnally adjusted baseline IOP at each study time point and at each study visit were calculated and no statistically significant differences were observed for the majority of endpoints. Mean diurnal IOP in the study eye at baseline was similar in both treatment groups: 25.1 mmHg for NET/LAT and 24.8 mmHg for BIM/TIM. Similar mean changes from diurnal baseline were observed at Month 3 for NET/LAT (– 9.4 mmHg) and BIM/TIM (–9.7 mmHg). No significant differences were observed in mean percent change in diurnal IOP from baseline for NET/LAT (–36.7%) and BIM/TIM (–38.6%) at Month 3 (Mean percent change from diurnally adjusted baseline IOP was similar for NET/LAT (–35.0% to –38.3%) compared to BIM/TIM (–34.8% to –40.2%) from Week 2 to Month 6; the majority of time points demonstrated no statistically significant difference between treatment groups. The efficacy profile for both treatment groups with or without prior PGA therapy is shown in Supplementary Fig. 