Clinical Efficacy of an Oil‐based Lubricant Eye Drop in Dry Eye Patients with Lipid Deficiency

Purpose To demonstrate the superior efficacy of a propylene glycol‐based, micro‐emulsion eye drop ( SYSB ; Systane ® Balance) over Preservative‐Free 0.9% Saline ( PFS ) Solution in patients with lipid‐deficient dry eye. Methods This was a multicenter, observer masked, parallel‐design study (powered to show superiority). Subjects were randomized to receive SYSB or PFS QID for 35 days (Phase 1) and then as needed for 55 days (Phase 2). Eligible subjects had lipid‐deficient dry eye with meibomian gland dysfunction. Results A total of 279 patients were enrolled, 214 were randomized and 210 received the assigned study treatment. Baseline and demographic characteristics were similar between SYSB (n = 110) and PFS (n = 100) groups. At the end of the study, the mean change from baseline (± SEM ) in TFBUT at Day 35 was 1.5 (0.2) and 0.5 (0.2) for SYSB and PFS respectively, representing a difference of 1.0 (0.3), significantly in favor of SYSB (p = 0.0011). Twenty one (19.1%) patients receiving SYSB and 8 (8.0%) patients receiving PFS experienced ocular treatment‐emergent AE s. Conclusions SYSB demonstrated superior efficacy to PFS in patients with lipid‐deficient dry eye and was well tolerated over the 90 day of treatment.