The safety and efficacy of Xiidra compared to vehicle were studied in 2133 patients in 4 well-controlled, 12-week trials.1
Each of the 4 studies assessed the effect of Xiidra compared to vehicle on the signs and symptoms of Dry Eye Disease.1 Signs were assessed based on Inferior Corneal Staining Score (ICSS) on a scale of 0 to 4 in increments of 0.5. Results were reported as change from baseline at each visit.1
At 12 weeks, Xiidra reduced inferior corneal staining, as measured by the change in ICSS, compared to vehicle in 3 of the 4 studies (Studies 1, 2, and 4).1
HOW TO READ A FOREST PLOT
1The dot represents the mean treatment difference
2The horizontal bar through the dot represents the confidence interval—in this case, 95%
3The line at zero is the "null" or "no effect" line
A plot in which the entire range of data stays to the left of the Y-axis shows that the treatment effect can confidently be attributed to Xiidra, rather than to random chance.
The plot shown uses sample data.
STUDY 1
Treatment Difference (Xiidra – Vehicle) in ICSS1
Mean Change (SD) From Baseline in ICSS1
XIIDRA (n=58) |
VEHICLE (n=58) |
|---|---|
BASELINE 1.77 (0.515) |
BASELINE 1.65 (0.513) |
WEEK 2 0.06 (0.522) |
WEEK 2 0.24 (0.709) |
WEEK 6 0.08 (0.591) |
WEEK 6 0.19 (0.694) |
WEEK 12 0.04 (0.745) |
WEEK 12 0.38 (0.785) |
STUDY 2
Treatment Difference (Xiidra – Vehicle) in ICSS1
Mean Change (SD) From Baseline in ICSS1
XIIDRA (n=293) |
VEHICLE (n=295) |
|---|---|
BASELINE 1.84 (0.597) |
BASELINE 1.81 (0.599) |
WEEK 2 0.04 (0.734) |
WEEK 2 0.08 (0.771) |
WEEK 6 -0.14 (0.861) |
WEEK 6 -0.02 (0.893) |
WEEK 12 -0.07 (0.868) |
WEEK 12 0.17 (0.819) |
STUDY 3
Treatment Difference (Xiidra – Vehicle) in ICSS1
Mean Change (SD) From Baseline in ICSS1
XIIDRA (n=358) |
VEHICLE (n=360) |
|---|---|
BASELINE 2.39 (0.763) |
BASELINE 2.40 (0.722) |
WEEK 2 -0.48 (0.802) |
WEEK 2 -0.48 (0.798) |
WEEK 6 -0.69 (0.918) |
WEEK 6 -0.60 (0.899) |
WEEK 12 -0.73 (0.926) |
WEEK 12 -0.71 (0.943) |
STUDY 4
Treatment Difference (Xiidra – Vehicle) in ICSS1
Mean Change (SD) From Baseline in ICSS1
XIIDRA (n=355) |
VEHICLE (n=356) |
|---|---|
BASELINE 2.46 (0.681) |
BASELINE 2.46 (0.746) |
WEEK 2 -0.49 (0.914) |
WEEK 2 -0.44 (0.775) |
WEEK 6 -0.69 (0.941) |
WEEK 6 -0.66 (0.927) |
WEEK 12 -0.80 (0.939) |
WEEK 12 -0.63 (0.911) |
*Based on ANCOVA model adjusted for baseline value and randomization stratification factors. All randomized and treated patients were included in the analysis and missing data were imputed using last-available data. In Study 2, one vehicle-treated subject who did not have a study eye designated was excluded from analysis.1
†CI = Confidence Interval