背景:该研究旨在评估使用丙二醇-羟丙基-瓜尔胶(PG-HPG)纳米乳液润滑剂滴眼液对干眼症表现的多症状缓解,在患有干眼病(DED)的受试者中。
方法:这是一个后营销,prospective,在美国进行的单臂研究。年龄≥18岁的受试者,双眼泪液破裂时间(TBUT)≤10s,干眼症问卷-5(DEQ-5)\“水汪汪的眼睛\”症状评分1-4,灼热/刺痛的症状,由干眼对日常生活的影响确定的疼痛和疲劳的眼睛-症状困扰(IDEEL-SB)问卷,包括IDEEL-SB评分16-65。要求受试者在第0、14±2和28±2天完成IDEEL-SB和DEQ-5,并每天四次自我施用一滴PG-HPG,共28±2天。主要终点是疼痛症状在第28天的基线变化,刺痛/燃烧,和疲惫的眼睛在IDEEL-SB;和症状水汪汪的眼睛在DEQ-5。评估的其他终点是基线和第28±2天的角膜染色和TBUT;第28±2天的症状缓解(5点Likert量表)和安全性。
结果:在119名受试者中,95人完成了研究(平均±SD年龄61.2±13.0岁;女性69.5%)。在第28天,眼睛疼痛/疼痛症状的平均IDEEL-SB评分从基线显着降低(从基线变化-1.0±1.1),灼伤/刺痛的眼睛(从基线变化-1.1±0.9),和疲劳的眼睛(从基线变化-1.1±1.0)(所有p<0.0001)。在第28天,水汪汪眼症状的平均DEQ-5评分从基线显著降低(从基线的变化-0.9±1.0,p<0.0001)。第28天的角膜染色与基线相当。TBUT从基线改善至第28天。在李克特的音阶上,超过50%的受试者报告疼痛症状缓解,刺痛,燃烧的眼睛。三名(3.1%)受试者报告了因治疗引起的不良事件(非眼部)。
结论:PG-HPG纳米乳润滑剂滴眼液在28天内显著改善DED患者的多种干眼症状,没有新的安全问题。
背景:ClinicalTrials.gov标识符,NCT05056155。
BACKGROUND: The study aimed to evaluate multi-symptom relief of dry eye manifestations with the use of propylene glycol-hydroxypropyl-guar (PG-HPG) nanoemulsion lubricant eye drops, among subjects with dry eye disease (DED).
METHODS: This was a post-marketing, prospective, single-arm study conducted in the USA. Subjects aged ≥ 18 years, with tear breakup time (TBUT) ≤ 10 s for both eyes, dry eye questionnaire-5 (DEQ-5) \"watery eyes\" symptom score 1-4, symptoms of burning/stinging, sore and tired eyes as determined by impact of dry eye on everyday living-symptom bother (IDEEL-SB) questionnaire, and IDEEL-SB score 16-65 were included. Subjects were required to complete IDEEL-SB and DEQ-5 at days 0, 14 ± 2, and 28 ± 2, and self-administer one drop of PG-HPG four times daily for 28 ± 2 days. Primary endpoints were change from baseline at day 28 in symptoms of sore, stinging/burning, and tired eyes on IDEEL-SB; and symptom of watery eyes on DEQ-5. Other endpoints evaluated were corneal staining and TBUT at baseline and day 28 ± 2; symptom relief (5-point Likert scale) at day 28 ± 2, and safety.
RESULTS: Of 119 subjects enrolled, 95 completed the study (mean ± SD age 61.2 ± 13.0 years; female 69.5%). Mean IDEEL-SB scores reduced significantly from baseline at day 28 for symptoms of aching/sore eyes (change from baseline - 1.0 ± 1.1), burning/stinging eyes (change from baseline - 1.1 ± 0.9), and tired eyes (change from baseline - 1.1 ± 1.0) (all p < 0.0001). Mean DEQ-5 score for watery eye symptoms significantly reduced from baseline at day 28 (change from baseline - 0.9 ± 1.0, p < 0.0001). Corneal staining at day 28 was comparable to baseline. TBUT improved from baseline to day 28. On a Likert scale, more than 50% of subjects reported relief from symptoms of sore, stinging, and burning eyes. Three (3.1%) subjects reported treatment-emergent adverse events (non-ocular).
CONCLUSIONS: PG-HPG nanoemulsion lubricant eye drops significantly improved multiple dry eye symptoms in subjects with DED over 28 days, with no new safety concerns.
BACKGROUND: ClinicalTrials.gov Identifier, NCT05056155.