Table 2.
Tear Osmolarity Measure at Baseline, Six, and 12 Months Over All and by Treatment Groups
| Month | Statistic | All Combined | Omega-3 | Placebo | Mean Difference (95% CI) | P |
|---|---|---|---|---|---|---|
| 0 | No. of eyes/no. of patients | 794/405 | 520/265 | 274/140 | ||
| Osmolarity (mOsm/L), mean (SD) | 303 (16.2) | 304 (17.0) | 301 (14.4) | 3.0 (0.3, 5.7) | 0.03 | |
| Patients with abnormal osmolarity* (%) | 236/405 (58%) | 156 (59%) | 80 (57%) | 2.4% (−7.8%, 12.5%) | 0.65 | |
| 6 | No. of eyes/no. of patients | 676/346 | 446/229 | 230/117 | ||
| Osmolarity (mOsm/L): Mean (SD) | 303 (17.6) | 304 (18.1) | 301 (16.4) | 2.7 (−0.5, 6.0) | 0.10 | |
| Patients with abnormal osmolarity* (%) | 196/346 (57%) | 137 (60%) | 59 (51%) | 8.7% (−2.4%, 19.8%) | 0.12 | |
| Osmolarity change from baseline: mean (SD) | 1.1 (19.1) | 1.1 (19.5) | 1.0 (18.3) | 0.2 (−3.2, 3.5) | 0.93 | |
| 12 | No. of eyes/no. of patients | 695/357 | 462/237 | 233/120 | ||
| Osmolarity (mOsm/L): Mean (SD) | 303 (17.9) | 303 (18.2) | 303 (17.4) | −0.3 (−3.6, 3.0) | 0.87 | |
| Patients with abnormal osmolarity* (%) | 195/357 (55%) | 127 (54%) | 68 (57%) | −3.1% (−13.0%, 7.8%) | 0.58 | |
| Osmolarity change from baseline: mean (SD) | 0.7 (20.3) | −0.6 (21.2) | 3.4 (18.1) | −4.0 (−7.4, −0.5) | 0.03 |
*
Abnormal osmolarity defined as osmolarity >308 mOsm/L in either eye or an inter-eye difference >8 mOsm/L.