Aldeyra announces first patient enrolled in the phase III TRANQUILITY trial of reproxalap for the treatment of dry eye disease.

Aldeyra Therapeutics, Inc. announced enrollment of the first patient in the Phase III TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease . The multi-center randomized, double-masked, parallel design, vehicle-controlled clinical trial will assess the efficacy and safety of reproxalap compared to vehicle in objective sign endpoints of dry eye disease, including tear RASP (reactive aldehyde species) levels after single and multiple doses, and after exposure to a dry eye chamber; Schirmer test (tear volume) following a single dose; and conjunctival redness in the dry eye chamber over 90 minutes. A run-in cohort of 20 patients is expected to be completed this year. Results from the run-in will be used to power the main cohort of the trial, and will confirm primary and secondary endpoints.