Table 1.

Summary of Lifitegrast Trials

Study (subjects)	Design	Key eligibility criteria	Primary endpoint(s)
Phase 162 (N=28)	Single-center, randomized, double-masked, placebo-controlled, dose-escalation, safety, pharmacokinetic trial of 0.1%, 0.3%, 1.0%, and 5.0% lifitegrast ophthalmic solution vs placebo (vehicle) for 27 days	Normal healthy adults	TEAEs
Phase 28 (N=230) NCT 00926185	Multicenter, randomized (1:1:1:1), double-masked, placebo-controlled trial of 0.1%, 1.0%, and 5.0% lifitegrast ophthalmic solution BID vs placebo (vehicle) BID for 84 days using CAE for subject selection	STT >1 and <10 mm/5 min No active lid margin disease Corneal staining score ≥2.0 CAE induced ICSS increase CAE induced ODS increase	Sign: ICSS Symptom: none
Phase 39 OPUS-1 (N=588) NCT 01421498	Multicenter, randomized (1:1), double-masked, placebo-controlled trial of 5.0% lifitegrast ophthalmic solution BID vs placebo (vehicle) BID for 84 days using CAE for subject selection	STT ≥1 and ≤10 mm/5 min No active lid margin disease Corneal staining score ≥2.0 CAE induced ICSS increase CAE induced ODS increase	Sign: ICSS Symptom: VR-OSDI
Phase 310 OPUS-2 (N=718) NCT 01743729	Multicenter, randomized (1:1), double-masked, placebo-controlled trial of 5.0% lifitegrast ophthalmic solution BID vs placebo (vehicle) BID for 84 days	STT ≥1 and ≤10 mm/5 min No active lid margin disease Corneal staining score ≥2.0 Artificial tear use within 30 days EDS ≥40	Sign: ICSS Symptom: EDS
Phase 363 OPUS-3a (N=~700) NCT 02284516	Multicenter, randomized (1:1), double-masked, placebo-controlled trial of 5.0% lifitegrast ophthalmic solution BID vs placebo (vehicle) BID for 84 days	Artificial tear use within 30 days EDS ≥40	Symptom: EDS
Phase 364 SONATA (N=331) NCT 01636206	Multicenter, randomized (2:1), double-masked, placebo-controlled trial of 5.0% lifitegrast ophthalmic solution BID vs placebo (vehicle) BID for 1 year	STT ≥1 and ≤10 mm/5 min No active lid margin disease Total corneal staining score ≥2.0 EDS or eye discomfort score ≥40	TEAEs

Notes:

^aAs of March 1, 2016, only the topline results of OPUS-3 have been presented. EDS was the sole primary efficacy endpoint.

Abbreviations: BID, twice daily; CAE, controlled adverse environment; EDS, eye dryness score; ICSS, inferior corneal staining score; NCT, ClinicalTrials identifier number; ODS, ocular discomfort score; STT, Schirmer tear test without anesthesia; TEAEs, treatment-emergent adverse events; VR-OSDI, visual-related function subscale score of the Ocular Surface Disease Index.