STUDY 1 | STUDY 2 | |||||||
---|---|---|---|---|---|---|---|---|
TREATMENT (2 SPRAYS / NOSTRIL TWICE DAILY) |
N | BASELINE MEAN | CHANGE FROM BASELINE LS MEAN | TREATMENT EFFECT DIFFERENCE LS MEAN (95% CI) | N | BASELINE MEAN | CHANGE FROM BASELINE LS MEAN | TREATMENT EFFECT DIFFERENCE LS MEAN (95% CI) |
RYALTRISTM | 299 | 10.1 | ˗3.5 | – | 291 | 10.1 | ˗3.5 | – |
OLOPATADINE HCl NASAL SPRAY§ | 294 | 10.3 | ˗2.9 | ˗0.6‖ (˗1.0, ˗0.2) |
290 | 10.2 | ˗3.1 | ˗0.4‖ (˗0.8, ˗0.1) |
MOMETASONE FUROATE NASAL SPRAY§ | 294 | 10.2 | ˗3.1 | ˗0.4 (-0.8, 0.0) |
293 | 10.2 | ˗3.1 | ˗0.5‖ (˗0.9, ˗0.1) |
PLACEBO | 283 | 10.2 | ˗2.5 | ˗1.0,‖ (˗1.3, ˗0.6) |
290 | 10.3 | ˗2.4 | ˗1.1,‖ (˗1.5, ˗0.7) |
*Average of AM and PM rTNSS for each day (maximum score=12) and averaged over the 2-week treatment period.
‡Adapted from RYALTRISTM Nasal Spray approved prescribing information, Glenmark Specialty SA, Switzerland.
§Not commercially marketed.
‖Statistically significant difference from placebo (P<0.05) using gatekeeping strategy. Note: Statistical comparisons are to placebo.
Least square (LS) means, 95% confidence intervals (CIs), and P values were based on the mixed model for repeated measures model, adjusting for covariates that included treatment, site, baseline 12-hour reflective total nasal symptom, and study day as the within-patient effect.
STUDY 1 | STUDY 2 | |||||||
---|---|---|---|---|---|---|---|---|
TREATMENT (2 SPRAYS / NOSTRIL TWICE DAILY) |
N | BASELINE MEAN | CHANGE FROM BASELINE LS MEAN | TREATMENT EFFECT DIFFERENCE LS MEAN (95% CI) | N | BASELINE MEAN | CHANGE FROM BASELINE LS MEAN | TREATMENT EFFECT DIFFERENCE LS MEAN (95% CI) |
RYALTRISTM | 299 | 9.2 | ˗3.0 | – | 291 | 9.2 | ˗3.1 | – |
OLOPATADINE HCl NASAL SPRAY‡ | 294 | 9.4 | ˗2.5 | ˗0.5 (˗0.9, ˗0.2) |
290 | 9.4 | ˗2.7 | ˗0.4§ (˗0.8, ˗0.0) |
MOMETASONE FUROATE NASAL SPRAY‡ | 294 | 9.3 | ˗2.7 | ˗0.4 (˗0.7, ˗0.0) |
293 | 9.4 | ˗2.6 | ˗0.5§ (˗0.9, ˗0.1) |
PLACEBO | 283 | 9.3 | ˗2.1 | ˗0.9,§ (˗1.3, ˗0.6) |
290 | 9.6 | ˗2.2 | ˗0.9,§ (˗1.3, ˗0.6) |
*Average of AM and PM iTNSS for each day (maximum score=12) and averaged over the 2-week treatment period.
†Adapted from RYALTRISTM Nasal Spray approved prescribing information, Glenmark Specialty SA, Switzerland.
‡Not commercially marketed.
§Statistically significant difference from placebo (P<0.05) using gatekeeping strategy. Note: Statistical comparisons are to placebo.
Least square (LS) means, 95% confidence intervals (CIs), and P values were based on the mixed model for repeated measures model, adjusting for covariates that included treatment, site, baseline 12-hour reflective total ocular symptom, and study day as the within-patient effect.
References