Table 2. Summary of Responders With Improvement in Signs (ICSS and TCSS) and Symptoms (EDS and Global VAS) at Day 84, Overall and Stratified by Baseline Severity (Pooled Data)a.
| ICSS and EDS category at randomization | Response category | Participant group, No./total No. (%) | OR (95% CI) | Nominal P value | ||
|---|---|---|---|---|---|---|
| Placebo (n = 716) | Lifitegrast (n = 713) | For OR | For interaction | |||
| Overall | ≥30% Improvement in EDS | 388/716 (54.2) | 508/713 (71.2) | 2.10 (1.68-2.61) | <.001 | .11 |
| ≥1-Point improvement in ICSS | 313/716 (43.7) | 356/713 (49.9) | 1.29 (1.05-1.59) | .02 | .99 | |
| ≥3-Point improvement in TCSS | 172/716 (24.0) | 212/713 (29.7) | 1.40 (1.10-1.78) | .01 | .66 | |
| ≥30% Improvement in global VAS | 396/716 (55.3) | 482/713 (67.6) | 1.67 (1.34-2.07) | <.001 | <.001 | |
| ICSS≤1.5 and EDS<60 | ≥30% Improvement in EDS | 27/43 (62.8) | 30/42 (71.4) | 1.55 (0.62-3.90) | .35 | NA |
| ≥1-Point improvement in ICSS | 9/43 (20.9) | 11/42 (26.2) | 1.40 (0.49-3.97) | .53 | NA | |
| ≥3-Point improvement in TCSS | 8/43 (18.6) | 7/42 (16.7) | 0.81 (0.26-2.54) | .72 | NA | |
| ≥30% Improvement in global VAS | 27/43 (62.8) | 25/42 (59.5) | 0.90 (0.37-2.20) | .81 | NA | |
| ICSS≤1.5 and EDS≥60 | ≥30% Improvement in EDS | 31/62 (50.0) | 47/63 (74.6) | 2.93 (1.38-6.25) | .01 | NA |
| ≥1-Point improvement in ICSS | 12/62 (19.4) | 17/63 (27.0) | 1.22 (0.49-3.04) | .67 | NA | |
| ≥3-Point improvement in TCSS | 8/62 (12.9) | 14/63 (22.2) | 1.83 (0.69-4.85) | .22 | NA | |
| ≥30% Improvement in global VAS | 26/62 (41.9) | 49/63 (77.8) | 4.78 (2.19-10.45) | <.001 | NA | |
| ICSS>1.5 and EDS<60 | ≥30% Improvement in EDS | 129/207 (62.3) | 147/209 (70.3) | 1.44 (0.96-2.17) | .08 | NA |
| ≥1-Point improvement in ICSS | 92/207 (44.4) | 107/209 (51.2) | 1.31 (0.89-1.93) | .17 | NA | |
| ≥3-Point improvement in TCSS | 51/207 (24.6) | 59/209 (28.2) | 1.25 (0.80-1.95) | .33 | NA | |
| ≥30% Improvement in global VAS | 134/207 (64.7) | 133/209 (63.6) | 0.96 (0.64-1.43) | .83 | NA | |
| ICSS>1.5 and EDS≥60 | ≥30% Improvement in EDS | 201/404 (49.8) | 284/399 (71.2) | 2.50 (1.87-3.34) | <.001 | NA |
| ≥1-Point improvement in ICSS | 200/404 (49.5) | 221/399 (55.4) | 1.26 (0.96-1.67) | .10 | NA | |
| ≥3-Point improvement in TCSS | 105/404 (26.0) | 132/399 (33.1) | 1.49 (1.09-2.04) | .01 | NA | |
| ≥30% Improvement in global VAS | 209/404 (51.7) | 275/399 (68.9) | 2.04 (1.53-2.73) | <.001 | NA | |
Abbreviations: EDS, eye dryness score; ICSS, inferior corneal staining score; NA, not applicable; OR, odds ratio; TCSS, total corneal staining score; VAS, visual analog scale.
a
For both groups, includes intention-to-treat population with last observation carried forward. Scores are described in Table 1.