Table 1 Mean IOP values (mm Hg) during the study (PP population).
Review period | T‐Gel 0.1% MD | T‐Gel 0.1% SDU | Mean difference | Two sided 95% CIs on mean difference | Non‐inferiority |
---|---|---|---|---|---|
Mean (SD) (n = 72) | Mean (SD) (n = 74) | ||||
Baseline, H0 | 23.51 (1.75) | 23.76 (1.98) | |||
Baseline, H2 | 17.97 (2.95) | 18.07 (3.25) | |||
Change† | 5.54 (2.93) | 5.69 (3.51) | −0.15 | (−0.90; 0.60) | Accepted |
Mean reduction (%) | 23.42 (11.76) | 23.65 (13.85) | |||
Week 4, H0 | 17.63 (2.48) | 17.61 (2.46) | |||
Change† | 5.88 (2.69) | 6.15 (2.58) | −0.27 | (−0.88; 0.34) | Accepted |
Mean reduction (%) | 24.77 (10.80) | 25.65 (10.20) | |||
Week 12, H0 | 17.88 (2.88) | 18.13 (2.73) | |||
Change† | 5.63 (2.93) | 5.63 (2.76) | 0.00 | (−0.66; 0.66) | Accepted |
Mean reduction (%) | 23.78 (12.00) | 23.50 (11.07) | |||
Week 12, H2* | 16.09 (2.74) | 16.28 (2.63) | |||
Change† | 7.42 (2.92) | 7.48 (2.55) | −0.07 | (−0.72; 0.58) | Accepted |
Mean reduction (%) | 31.36 (11.75) | 31.39 (10.06) | |||
Last assessment, H0 | 17.88 (2.88) | 18.13 (2.73) | |||
Change† | 5.63 (2.93) | 5.63 (2.76) | 0.00 | (−0.66; 0.66) | Accepted |
Mean reduction (%) | 23.78 (12.00) | 23.50 (11.07) |
*One missing datum in the T‐Gel 0.1% MD group.
†Change in comparison with baseline H0.