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

INTRODUCTION

Dry eye disease (DED) symptoms can impair activities of daily living (ADLs) and work productivity (WP). This post hoc integrated analysis of the phase 2b COMET-1 (NCT04498182) and phase 3 COMET-2 (NCT05285644) and COMET-3 (NCT05360966) studies explored the effectiveness of acoltremon ophthalmic solution 0.003% (ACO [Tryptyr®]), 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.