Table 3. Reduction of Itching Scores by Pataday and Pazeo in Human Subjectsa.
| Pazeo (olopatadine, 0.7%) | Pataday
(olopatadine, 0.2%) |
Vehicle |
||||
|---|---|---|---|---|---|---|
| time point | mean | mean | difference (95% CI) | mean | difference (95% CI) | |
| Study 1 | N = 66 | (N = 68) | (N = 68) | |||
| onset | 3 min | 0.36 | 0.39 | –0.02 (−0.31 0.26) | 1.90 | –1.54 (−1.82 −1.25) |
| 5 min | 0.53 | 0.61 | –0.08 (−0.39 0.22) | 2.06 | –1.53 (−1.84 −1.22) | |
| 7 min | 0.48 | 0.61 | –0.13 (−0.44 0.17) | 1.97 | –1.49 (−1.80 −1.18) | |
| 16 h | 3 min | 0.70 | 0.87 | –0.17 (−0.44 0–11) | 2.20 | –1.50 (−1.77 −1.23) |
| 5 min | 0.79 | 1.04 | –0.24 (−0.55 0.07) | 2.27 | –1.4S (−1.79 −1.16) | |
| 7 min | 0.75 | 0.98 | –0.23 (−0.54 0.08) | 2.13 | –1.38 (−1.69 −1.07) | |
| 24 h | 3 min | 0.93 | 1.41 | –0.48 (−0.76 −0.20) | 2.54 | –1.61 (−1.88 −1.33) |
| 5 min | 1.10 | 1.52 | –0.42 (−0.72 −0.12) | 2.62 | –1.51 (−1.81 −1.21) | |
| 7 min | 1.09 | 1.50 | –0.41 (−0.72 −0.10) | 2.50 | –1.41 (−1.72 −1.11) | |
| Study 2 | (N = 98) | (N = 99) | (N = 49) | |||
| onset | 3 min | 0.38 | 0.47 | –0.09 (−0.28 0.09) | 1.91 | –1.53 (−1.76 −1.30) |
| 5 min | 0.53 | 0.61 | –0.08 (−0.29 0.12) | 1.99 | –1.46 (−1.71 −1.22) | |
| 7 min | 0.65 | 0.61 | 0.04 (−0.18 0.26) | 1.82 | –1.17 (−1.45 −0.90) | |
| 24 h | 3 min | 1.01 | 1.33 | –0.31 (−0.57 −0.06) | 2.30 | –1.29 (−1.60 −0.97) |
| 5 min | 1.22 | 1.48 | –0.26 (−0.51 -0.01) | 2.37 | –1.15 (−1.46 -0.84) | |
| 7 min | 1.25 | 1.41 | –0.16 (−0.42 0.11) | 2.14 | –0.89 (−1.22 −0.57) | |
a
Mean score estimates, treatment differences, and corresponding 95% confidence intervals (CIs) were based on analysis of repeated measures using a mined model with itching scores frm each eye (left or right) as the dependent variable and fixed effect terms for investigator, treatment, eye-type (left or right), time, and treatment-by-time interaction. The ocular itching score range is 0–4, where 0 is none and 4 is incapacitating itch. The comparative clinical data shown above are from the package insert of Pazeo available from the FDA Web site.