Improvement in Visual-Tasking Daily Living Activities and Work Productivity in Patients with Dry Eye Disease: Integrated Analysis of COMET Studies

INTRODUCTION: ]), a recently approved treatment for DED signs and symptoms, on visual-tasking ADLs and WP. METHODS: These randomized, double-masked, vehicle (VEH)-controlled studies had similar designs and identical eligibility criteria, enrolling adults aged ≥ 30 years with prespecified DED signs and symptoms. Patients were randomized 1:1 to receive ACO or VEH in both eyes twice daily for 84 (COMET-1) or 90 (COMET-2 and COMET-3) days. The degree that DED symptoms interfered with visual-tasking ADLs and WP was assessed on visual analog scales (VAS; 0-100 mm). ADL/WP and Symptom Assessment iN Dry Eye (SANDE) questionnaires and safety assessments were collected on days 1, 14, 28, and 84/90. Least-squares (LS) mean change from baseline (CFB) and responder analyses were analyzed using analysis of covariance and Cochran-Mantel-Haenszel test, respectively. RESULTS: Positive treatment effects in favor of ACO (n = 584) versus VEH (n = 595) were observed for LS mean difference in CFB from days 14 through 84/90 in the ability to use electronic devices (day 14, - 4.4 [P = 0.0016]; day 28, - 5.4 [P = 0.0002]; day 84/90, - 3.4 [P = 0.0378]), a visual-tasking composite score (day 14, - 3.7 [P = 0.0023]; day 28, - 4.2 [P = 0.0012]; day 84/90, - 3.1 [P = 0.0307]), and WP (day 14, - 4.4 [P = 0.0104]; day 28, - 5.4 [P = 0.0028]; day 84/90, - 4.4 [P = 0.0229]). Responder analyses favoring ACO supported the meaningfulness of observed CFB reductions. The only ocular treatment-emergent adverse event with > 1.5% incidence was instillation-site burning or stinging (ACO, 50.2% [97.6% mild]; VEH, 3.2% [100% mild]). CONCLUSIONS: These exploratory data suggest that ACO is associated with rapid and sustained improvements in visual-tasking ADLs and WP. TRIAL REGISTRATION: COMET-1, NCT04498182; COMET-2, NCT05285644; COMET-3, NCT05360966.