Cornea · 2025
Factors Associated With Perfluorohexyloctane Treatment Response in Dry Eye Disease Associated With Meibomian Gland Dysfunction.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Gu Hao, Li Zhanrong, Zhu Lei
Аннотация
PURPOSE: To explore critical factors associated with perfluorohexyloctane eye drop (SHR8058) treatment response in patients with dry eye disease associated with meibomian gland dysfunction.
METHODS: 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.
RESULTS: 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)].
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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)].
CONCLUSIONS: 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.