TABLE I.

Responder analyses

	CsA CE, n	Vehicle, n
Planned responder analyses
In patients with moderate to severe DED	241	248
Ocular discomfort responders = ≥25% improvement in VAS
Complete responders = CFS score of 0
Post hoc responder analyses
In patients with CFS score ≥3 and OSDI score ≥23 at baseline	128	118
CFS responders = ≥2 grades improvement
OSDI responders = ≥30% improvement
Co-responders = improvement of ≥2 grades in CFS and ≥30% in OSDI
In patients with CFS score of 4 at baseline	43	42
CFS responders = ≥2 grades improvement
Co-responders = improvement of ≥2 grades in CFS and ≥30% in OSDI
In patients with CFS score of 2 at baseline	83	93
Complete responders = CFS score of 0

N reflects the number of patients included in the full analysis set.

CsA CE = 0.1% cyclosporine A cationic emulsion; CFS = corneal fluorescein staining; DED = dry eye disease; OSDI = ocular surface disease index; VAS = visual analogue scale.