First patient dosed in Kala dry eye treatment trial
The first patient has been dosed in a phase 3 trial of Kala Pharmaceuticals’ short-term dry eye treatment KPI-121 0.25%, the company announced in a press release.
The STRIDE 3 multicenter, randomized, double-masked, placebo-controlled, parallel arm trial will compare KPI-121 0.25% to placebo in approximately 900 patients with dry eye, with the primary endpoint being patient report of discomfort severity at day 15. Patients will be dosed four times a day for 14 days.
“If approved, KPI-121 0.25% could be the first FDA- approved product for the short-term treatment of dry eye disease,” Kala’s chief medical officer Kim Brazzell said. “The STRIDE 3 trial design reflects specific modifications to the inclusion/exclusion criteria of our previous trials to address key factors which we believe will improve the probability of success. We anticipate reporting topline results in the fourth quarter of 2019.”