<p>Study dataset.</p>

<div> <p>Purpose</p><p>This study aimed to evaluate the efficacy and safety of low-concentration, nanoparticle-based cyclosporine eye drops (SCAI-001 0.01% and SCAI-001 0.02%) compared to those of the conventional Restasis^® (cyclosporine 0.05%) emulsion for dry eye disease (DED).</p> <p>Methods</p><p>In this multicenter, randomized, double-blind, Phase 2 trial, patients with DED were assigned to three groups: SCAI-001 0.01%, SCAI-001 0.02%, and Restasis.

The primary efficacy endpoint was the change in tear volume after 12 weeks. Secondary efficacy endpoints included changes in tear volume at 4 and 8 weeks, corneal and conjunctival surface staining scores, tear film breakup time (TBUT), standard patient evaluation of eye dryness questionnaire score (SPEED), and ocular surface disease index (OSDI) at 4, 8, and 12 weeks.</p> <p>Results</p><p>Tear volume increased in all groups at 12 weeks without intergroup differences.