Reproxalap Improves Ocular Redness, Tear Production, and Symptoms in a Pivotal Dry Eye Disease Chamber Trial.

Purpose: The primary objective was to assess the acute efficacy of 0.25% reproxalap ophthalmic solution versus vehicle in patients with dry eye disease. Design: This was a vehicle-controlled, randomized-sequence, double-masked, 2-period crossover trial. Participants and Controls: Sixty-three patients with dry eye disease were treated with reproxalap or vehicle in 2 treatment periods. Methods: For each treatment period, patients were treated 4 times for 1 day, followed the next day by 1 dose before and 1 dose during a 90-minute dry eye chamber. Washout between treatment periods was 7 to 14 days. Main Outcome Measures: The primary endpoints were ocular redness during the chamber and Schirmer test 10 minutes after the fourth dose on the prechamber day. The key secondary endpoint was ≥10 mm unanesthetized Schirmer test responders. Other secondary endpoints included symptoms in the chamber. Results: Relative to vehicle, reproxalap treatment statistically significantly diminished ocular redness and increased Schirmer score and percent ≥10-mm responders. All symptoms assessed in the chamber were statistically significantly lower after treatment with reproxalap versus vehicle. The most common adverse event in patients treated with reproxalap was mild transient instillation site irritation, most commonly lasting ≤1 minute. Conclusions: Within minutes of administration to dry eye disease patients, reproxalap increased tear production, and decreased ocular redness and improved symptoms in a dry eye chamber. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.