透明质酸钠、黄原胶和渗透保护剂眼药水治疗干眼病的疗效与安全性：一项观察性临床研究。
Performance and Safety of a Sodium Hyaluronate, Xanthan Gum, and Osmoprotectants Ophthalmic Solution in the Treatment of Dry Eye Disease: An Observational Clinical Investigation.
作者信息
Molero Senosiaín Mercedes, Burgos-Blasco Barbara, Perez-García Pilar, Sánchez-Ventosa Álvaro, Villalba-González Marta, López Pérez María Dolores, Díaz José Carlos, Díaz-Mesa Vanesa, Villarrubia Cuadrado Alberto, Artiaga Elordi Enrique, Larrosa Poves Jose Manuel, Blasco Alejandro, Mateo Antonio, Civiale Claudine, Bonino Laura, Cano-Ortiz Antonio
机构信息
Ophthalmology Department Hospital Clínico San Carlos, C. de Isaac Peral, 58, Moncloa-Aravaca, 28040, Madrid, Spain.
Department of Anterior Segment, Cornea and Refractive Surgery, Hospital Arruzafa, Córdoba, Spain.
出版信息
Ophthalmol Ther. 2025 Apr;14(4):675-692. doi: 10.1007/s40123-025-01099-x. Epub 2025 Feb 21.
INTRODUCTION
Dry eye disease (DED) is characterized by an imbalance in the tear film, resulting in symptoms such as dryness, redness, and discomfort. The management of DED involves tear supplements, medications, or surgery in severe cases. To evaluate the clinical performance and safety of a hypotonic ophthalmic solution containing sodium hyaluronate 0.2%, xanthan gum 0.2%, and osmoprotectants (glycine and betaine) for treating DED.
METHODS
This multicenter, prospective, observational clinical investigation included 35 subjects treated with one drop of the ophthalmic solution four times daily. Evaluations were conducted at baseline, on day 14, and at 1 and 3 months. The investigation assessed corneal and conjunctival fluorescein staining (NEI score), hyperemia index (Keratograph®), fluorescein tear film break-up time (TFBUT), best-corrected visual acuity, dry eye symptoms (SANDE), and quality of life (DEQS). Safety was monitored through adverse events, intraocular pressure measurements, and the Investigator Global Assessment of Safety.
RESULTS
Subjects were predominantly female (93.9%), with an average age of 59.9 ± 13.8 years. The ophthalmic solution significantly reduced keratitis lesions with global NEI score decreasing from baseline at 1 month (- 6.67 ± 4.6, p = 0.001) and 3 months (- 7.61 ± 4.0 points; p = 0.001). Conjunctival hyperemia improved significantly after 1 month (- 0.34 ± 0.7 points; p = 0.027), while fluorescein tear film stability increased significantly at 1 (1.85 ± 3.1 s; p = 0.002) and 3 months (1.98 ± 3.4 s; p = 0.001). Symptoms also improved significantly (p = 0.001) at 1 and 3 months (- 29.37 ± 22.2 points and - 26.41 ± 24.0 points, respectively), as did quality of life (- 20.81 ± 15.6 points at 1 month and - 18.43 ± 19.3 points at 3 months; p = 0.001 for both). The safety profile was very good, with no adverse events (only mild ocular discomfort reported in 14.3% of subjects).
CONCLUSIONS
The ophthalmic solution effectively improved DED symptoms and signs, enhancing patients' quality of life while maintaining a good safety profile.
TRIAL REGISTRATION NUMBER
NCT05778942.
引言
干眼疾病（DED）的特征是泪膜失衡，导致眼睛干涩、发红和不适等症状。DED的治疗包括泪液补充剂、药物治疗，严重情况下还包括手术治疗。本研究旨在评估一种含有0.2%透明质酸钠、0.2%黄原胶和渗透压保护剂（甘氨酸和甜菜碱）的低渗眼科溶液治疗DED的临床疗效和安全性。
方法
这项多中心、前瞻性、观察性临床研究纳入了35名受试者，他们每天使用一滴该眼科溶液，每天4次。在基线、第14天、1个月和3个月时进行评估。研究评估了角膜和结膜荧光素染色（NEI评分）、充血指数（Keratograph®）、荧光素泪膜破裂时间（TFBUT）、最佳矫正视力、干眼症状（SANDE）和生活质量（DEQS）。通过不良事件、眼压测量和研究者整体安全性评估来监测安全性。
结果
受试者以女性为主（93.9%），平均年龄为59.9±13.8岁。该眼科溶液显著减少了角膜炎病变，整体NEI评分在1个月时较基线下降（-6.67±4.6，p=0.001），在3个月时下降（-7.61±4.0分；p=0.001）。结膜充血在1个月后显著改善（-0.34±0.7分；p=0.027），而荧光素泪膜稳定性在1个月（1.85±3.1秒；p=0.002）和3个月时显著增加（1.98±3.4秒；p=0.001）。症状在1个月和3个月时也显著改善（p=0.001）（分别为-29.37±22.2分和-26.41±24.0分），生活质量也是如此（1个月时为-20.81±15.6分，3个月时为-18.43±19.3分；两者p均=0.001）。安全性良好，未发生不良事件（仅14.3%的受试者报告有轻度眼部不适）。
结论
该眼科溶液有效改善了DED的症状和体征，提高了患者的生活质量，同时保持了良好的安全性。
试验注册号
NCT05778942。
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