Table 8.
Patients at endpoint, n | Tear film breakup time,a mean ± SD, seconds
|
Corneal staining,b mean ± SD, units
|
|||
---|---|---|---|---|---|
Baseline | Endpointc | Baseline | Endpointc | ||
Current study | |||||
Systane Balance, 1 month | 48 | 5.3 ± 2.3 | 6.0 ± 2.2 (P < 0.05) |
4.1 ± 2.3 | 3.1 ± 2.1 (P < 0.001) |
Reference study30 | |||||
Cyclosporine, 0.5%, 3 months | 12 | 9.9 ± 10.3 | 10.8 ± 8.0 (P = 0.08) |
3.3 ± 2.4 | 1.3 ± 1.9 (P = 0.01) |
Artificial tears, 3 months | 14 | 7.4 ± 6.6 | 6.1 ± 3.8 (P = 0.08) |
4.4 ± 3.0 | 3.9 ± 2.9 (P = 0.01) |
Notes:
Current study, average-eye analysis, replicate 1 of 2; reference study, worst-eye analysis;
current study, average-eye analysis, scale 0 to 15; reference study, worst-eye analysis, scale 0 to 12;
current study, significance versus baseline; reference study, significance versus comparator arm.
Abbreviation: SD, standard deviation.