Table 1.
Summary of trials included in the pooled analysisa.
| Phase II | OPUS-1, phase III | OPUS-2, phase III | OPUS-3, phase III | SONATA, phase III | |
|---|---|---|---|---|---|
| ClinicalTrials.gov registration | NCT00926185 | NCT01421498 | NCT01743729 | NCT02284516 | NCT01636206 |
| Sample size | 230 | 588 | 718 | 711 | 331 |
| Study arms (n in each arm, safety population) |
Placebo (58), lifitegrast 0.1% (57),b 1.0% (57),b 5.0% (58) |
Placebo (295), lifitegrast 5.0% (293) |
Placebo (359), lifitegrast 5.0% (359) |
Placebo (354), lifitegrast 5.0% (357) |
Placebo (111), lifitegrast 5.0% (220) |
| Objectives | Efficacy and safety | Efficacy and safety | Efficacy and safety | Efficacy and safety | Safety |
| Schedule | BID for 84 days | BID for 84 days | BID for 84 days | BID for 84 days | BID for 360 days |
| CAE in participant selection | Yes | Yes | No | No | No |
| Key inclusion criteria | Adults with DED (⩾18 years of age) Corneal staining scorec ⩾2.0 (pre CAE) Redness scored ⩾1.0 pre CAE STT score ⩾1 and ⩽10 Change in ICSS ⩾1 (post minus pre CAE) ODS ⩾3 at 2 consecutive time points during CAE 1 and 2 |
Adults with DED (⩾18 years of age) Corneal staining scorec ⩾2.0 (pre CAE) Redness scored ⩾1.0 pre CAE STT score ⩾1 and ⩽10 Change in ICSS ⩾1 (post minus pre CAE) ODS ⩾3 at 2 consecutive time points during CAE 1 and 2 |
Adults with DED (⩾18 years of age) Corneal staining scorec ⩾2.0 Redness scored ⩾1.0 STT score ⩾1 and ⩽10 EDS ⩾40, both eyes ICSS ⩾0.5 Artificial tear use within 30 days |
Adults with DED (⩾18 years of age) Corneal staining scorec ⩾2.0 Redness scored ⩾1.0 STT score ⩾1 and ⩽10 EDS ⩾40, both eyes ICSS ⩾0.5 Artificial tear use within 30 days |
Adults with DED (⩾18 years of age) Corneal staining scorec ⩾2.0 STT score ⩾1 and ⩽10 EDS or eye discomfort score ⩾40 (VAS) |
BID: twice daily; CAE: controlled adverse environment; DED: dry eye disease; EDS: eye dryness score (VAS, 0–100 scale; 0: no discomfort); ICSS: inferior corneal staining score (0–4 scale); ODS: ocular discomfort score (0–4 scale; 0 = no discomfort); STT: Schirmer tear test (without anesthesia; mm/5 min); VAS: visual analog scale.
Further details summarized in Holland et al.7
Data were not included in the pooled safety analyses for the 0.1% and 1.0% dose groups.
Corneal staining was performed as instillation of 5 µL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye; participants had scores ⩾2 (0–4 scale) in ⩾1 region(s) in ⩾1 eye(s).
Redness score (0-4 scale; 0 = none, 4 = severe).