Motugivatrep (SJP-0132) 0.3% Ophthalmic Suspension for Dry Eye Disease: A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Trial

Purpose

To evaluate the efficacy and safety of motugivatrep (SJP-0132) 0.3% ophthalmic suspension, a novel therapy targeting subjective symptoms, in patients with dry eye disease. Patients and methods: This pivotal, multicenter, randomized, double-masked, placebo-controlled Phase 3 study was conducted in Japan. Outpatients with dry eye-related subjective symptoms and short tear break-up times (TBUT; ≤5 seconds in both eyes) were randomized 1:1 to receive motugivatrep 0.3% ophthalmic suspension or placebo four times daily for 8 weeks. The primary endpoint was the change from baseline in total Dry Eye-related Quality of Life Score (DEQS) at week 4.