Factors Associated With Perfluorohexyloctane Treatment Response in Dry Eye Disease Associated With Meibomian Gland Dysfunction

To explore critical factors associated with perfluorohexyloctane eye drop (SHR8058) treatment response in patients with dry eye disease associated with meibomian gland dysfunction. The post hoc analysis was performed from a phase 3, randomized controlled trial (NCT05515471). Treatment response was defined as achieving 1) a ≥ 3-point reduction from baseline in total corneal fluorescein staining (tCFS response), 2) a ≥30% reduction from baseline in eye dryness score (EDS response), or 3) both tCFS and eye dryness score (EDS) responses (tCFS&EDS response) at day 57. Univariate and multivariate logistic regression analyses using stepwise selection were conducted. Optimal cutoff values were also investigated. Among the 156 patients treated with SHR8058, 114 achieved a tCFS response, 127 achieved an EDS response, and 98 achieved a tCFS&EDS response. Multivariate analysis revealed tCFS score was associated with tCFS, EDS, and tCFS&EDS responses, with odds ratios (ORs) of 1.37 [95% confidence interval (CI), 1.08-1.73], 1.36 (95% CI, 1.05-1.77), and 1.39 (95% CI, 1.13-1.72), respectively. Ametropia was associated with tCFS and tCFS&EDS responses, with ORs of 3.03 (95% CI, 1.27-7.25) and 2.32 (95% CI, 1.10-4.88), respectively. Moreover, patients with baseline a tCFS score ≥6 were more likely to achieve a tCFS&EDS response compared with those with a tCFS score <6 [OR 3.25 (95% CI, 1.62-6.53)]. Baseline tCFS score and ametropia are critical factors associated with SHR8058 treatment response. Patients with a baseline tCFS score ≥6 and those with ametropia are more likely to achieve greater overall improvements of corneal surface condition and dry eye symptoms.