Table 3.
Baseline (N=535) | 6 Months (N=481) | 12 Months (N=488) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Characteristic | N | Mean(SD)a | rs | P | N | Mean(SD)a | rs | P | N | Mean(SD)a | rs | P |
Signs | ||||||||||||
Conjunctival staining score | 535 | 2.9 (1.4) | 0.04 | 0.36 | 481 | 2.6 (1.5) | 0.04 | 0.41 | 488 | 2.5 (1.5) | 0.10 | 0.02 |
Corneal staining score | 535 | 3.8 (2.8) | 0.12 | 0.006 | 481 | 3.3 (2.7) | 0.11 | 0.02 | 488 | 3.2 (2.7) | 0.06 | 0.17 |
Tear break-up time (seconds) | 535 | 3.1 (1.6) | −0.05 | 0.25 | 481 | 3.7 (2.5) | −0.08 | 0.08 | 488 | 3.8 (2.3) | −0.07 | 0.13 |
Schirmer test (mm) | 535 | 9.6 (6.7) | −0.10 | 0.02 | 477 | 10.0 (6.6) | −0.01 | 0.84 | 484 | 9.9 (6.4) | −0.04 | 0.39 |
OSDI (lower is better) | ||||||||||||
Total score | 535 | 42.1 (15.5) | 0.47 | <0.001 | 481 | 32.2 (19.1) | 0.61 | <0.001 | 488 | 30.5 (18.6) | 0.67 | <0.001 |
Vision-related function | 535 | 35.2 (19.2) | 0.23 | <0.001 | 481 | 26.5 (21.1) | 0.47 | <0.001 | 488 | 24.7 (20.7) | 0.53 | <0.001 |
Ocular symptoms | 535 | 45.1 (19.1) | 0.44 | <0.001 | 481 | 34.7 (21.8) | 0.56 | <0.001 | 488 | 32.9 (22.1) | 0.57 | <0.001 |
Environmental triggers | 529 | 52.6 (26.8) | 0.38 | <0.001 | 475 | 41.1 (29.6) | 0.50 | <0.001 | 481 | 39.6 (29.0) | 0.51 | <0.001 |
SF-36 (higher is better) | ||||||||||||
Summary: Physical Health | 535 | 47.5 (9.7) | −0.10 | 0.02 | 478 | 47.7 (10.3) | −0.19 | <0.001 | 486 | 47.7 (10.2) | −0.18 | <0.001 |
Physical Functioning | 535 | 48.3 (9.6) | −0.06 | 0.13 | 478 | 48.4 (9.7) | −0.12 | 0.01 | 487 | 48.4 (9.7) | −0.17 | <0.001 |
Role Limitations-Physical Health | 535 | 47.5 (9.6) | −0.14 | 0.001 | 479 | 47.4 (10.0) | −0.22 | <0.001 | 487 | 48.0 (10.0) | −0.23 | <0.001 |
Bodily Pain | 535 | 47.3 (9.7) | −0.10 | 0.02 | 479 | 47.3 (10.1) | −0.28 | <0.001 | 487 | 47.5 (9.9) | −0.21 | <0.001 |
General Health Perceptions | 535 | 52.0 (10.2) | −0.13 | 0.003 | 479 | 51.5 (10.7) | −0.16 | <0.001 | 487 | 51.5 (10.4) | −0.13 | 0.003 |
Summary: Mental Health | 535 | 52.3 (9.4) | −0.11 | 0.01 | 479 | 51.7 (9.8) | −0.19 | <0.001 | 486 | 52.2 (9.0) | −0.18 | <0.001 |
Vitality | 535 | 51.3 (9.8) | −0.12 | 0.005 | 479 | 51.1 (10.3) | −0.21 | <0.001 | 486 | 51.3 (9.7) | −0.21 | <0.001 |
Social Functioning | 535 | 49.6 (9.6) | −0.12 | 0.006 | 479 | 49.6 (9.9) | −0.24 | <0.001 | 487 | 49.6 (9.4) | −0.18 | <0.001 |
Role Limitations-Emotional Problems | 535 | 50.1 (9.3) | −0.12 | 0.007 | 479 | 49.6 (9.6) | −0.16 | <0.001 | 487 | 50.3 (9.3) | −0.20 | <0.001 |
Mental Health | 535 | 52.4 (8.6) | −0.13 | 0.004 | 479 | 51.6 (9.2) | −0.22 | <0.001 | 486 | 52.2 (8.6) | −0.20 | <0.001 |
Brief Ocular Discomfort Index | ||||||||||||
Interference with activities of daily living (lower is better) | ||||||||||||
General activity | 535 | 33.1 (23.1) | 0.60 | <0.001 | 481 | 25.2 (24.7) | 0.63 | <0.001 | 488 | 22.2 (24.2) | 0.65 | <0.001 |
Mood | 535 | 28.6 (24.1) | 0.52 | <0.001 | 481 | 21.9 (23.7) | 0.55 | <0.001 | 488 | 18.4 (22.1) | 0.56 | <0.001 |
Walking ability | 534 | 18.2 (22.2) | 0.37 | <0.001 | 481 | 13.7 (21.4) | 0.39 | <0.001 | 488 | 12.2 (19.6) | 0.44 | <0.001 |
Normal work | 535 | 29.9 (23.7) | 0.51 | <0.001 | 481 | 21.5 (23.3) | 0.56 | <0.001 | 488 | 19.3 (22.5) | 0.57 | <0.001 |
Relations with other people | 535 | 17.1 (21.0) | 0.40 | <0.001 | 481 | 12.6 (19.9) | 0.44 | <0.001 | 488 | 11.7 (19.4) | 0.48 | <0.001 |
Sleep | 535 | 20.0 (23.8) | 0.40 | <0.001 | 481 | 15.3 (20.9) | 0.44 | <0.001 | 488 | 13.3 (20.4) | 0.40 | <0.001 |
Enjoyment of life | 535 | 25.7 (23.5) | 0.51 | <0.001 | 481 | 19.3 (22.4) | 0.52 | <0.001 | 488 | 17.4 (22.1) | 0.56 | <0.001 |
Relief from treatment (higher is better) | 534 | 38.5 (27.5) | −0.02 | 0.60 | 479 | 44.2 (31.3) | −0.08 | 0.07 | 483 | 45.8 (32.0) | −0.02 | 0.61 |
SD is standard deviation