Bickle Katherine, Miller Jason R, Tauber Joseph, Awisi-Gyau Deborah
Procare Vision Center, 1955 Newark-Granville Road, Granville, OH, 43023, USA.
Insight Research Clinic LLC d/b/a Eyecare Professionals, Inc., 9711-C Sawmill Parkway, Powell, OH, 43065, USA.
Ophthalmol Ther. 2024 Feb;13(2):481-494. doi: 10.1007/s40123-023-00853-3. Epub 2023 Dec 11.
INTRODUCTION: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier, NCT05056155.
引言：本研究旨在评估使用丙二醇 - 羟丙基瓜尔胶（PG - HPG）纳米乳剂润滑眼药水对干眼症（DED）患者多种干眼症状的缓解情况。 方法：这是一项在美国进行的上市后前瞻性单臂研究。纳入年龄≥18岁、双眼泪膜破裂时间（TBUT）≤10秒、干眼问卷 - 5（DEQ - 5）中“泪眼”症状评分为1 - 4分、根据干眼对日常生活的影响 - 症状困扰（IDEEL - SB）问卷确定有眼烧灼感/刺痛感、眼痛和眼疲劳症状且IDEEL - SB评分为16 - 65分的受试者。受试者需在第0天、第14±2天和第28±2天完成IDEEL - SB和DEQ - 5问卷，并每天自行滴入一滴PG - HPG，共28±2天。主要终点为第28天IDEEL - SB问卷中眼痛、刺痛/烧灼感和眼疲劳症状相对于基线的变化；以及DEQ - 5问卷中泪眼症状的变化。评估的其他终点包括基线和第28±2天的角膜染色和TBUT；第28±2天的症状缓解情况（5级李克特量表）以及安全性。 结果：在纳入的119名受试者中，95名完成了研究（平均±标准差年龄61.2±13.0岁；女性占69.5%）。在第28天，与基线相比，IDEEL - SB问卷中眼酸痛（相对于基线变化 - 1.0±1.1）、眼烧灼感/刺痛感（相对于基线变化 - 1.1±0.9）和眼疲劳（相对于基线变化 - 1.1±1.0）的平均得分显著降低（所有p<0.0001）。第28天DEQ - 5问卷中泪眼症状的平均得分相对于基线显著降低（相对于基线变化 - 0.9±1.0，p<0.0001）。第28天的角膜染色与基线相当。TBUT从基线到第28天有所改善。在李克特量表上，超过50%的受试者报告眼酸痛、刺痛和烧灼感症状得到缓解。三名（3.1%）受试者报告了治疗中出现的不良事件（非眼部）。 结论：PG - HPG纳米乳剂润滑眼药水在28天内显著改善了DED患者的多种干眼症状，且无新的安全问题。 试验注册：ClinicalTrials.gov标识符，NCT05056155。
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