The first participant has been dosed in the phase 3 registrational COMET-2 study of AR-15512 ophthalmic solution for the treatment of dry eye disease signs and symptoms, according to a press release from Aerie Pharmaceuticals.
Approximately 460 participants at 20 U.S. sites will receive AR-15512 0.003% or AR-15512 vehicle twice daily in each eye for 3 months in the randomized, double-masked, vehicle-controlled multicenter clinical study. Tear production measured by Schirmer test is the primary efficacy assessment, with the key secondary measure consisting of dry eye symptoms based on the SANDE