Department of Sense Organs, University Sapienza of Rome, Rome, Italy.
Department of Sense Organs, University Sapienza of Rome, Rome, Italy
Br J Ophthalmol. 2020 Jan;104(1):127-135. doi: 10.1136/bjophthalmol-2018-312470. Epub 2019 Apr 3.
Dry eye disease (DED) affects more than 14% of the elderly population causing decrease of quality of life, high costs and vision impairment. Current treatments for DED aim at lubricating and controlling inflammation of the ocular surface. Development of novel therapies targeting different pathogenic mechanisms is sought-after. The aim of this study is to evaluate safety and efficacy of recombinant human nerve growth factor (rhNGF) eye drops in patients with DED.
Forty consecutive patients with moderate to severe DED were included in a phase IIa, prospective, open label, multiple-dose, clinical trial to receive rhNGF eye drops at 20 µg/mL (Group 1: G1) or at 4 µg/mL (Group 2: G2) concentrations, two times a day in both eyes for 28 days (NCT02101281). The primary outcomes measures were treatment-emerged adverse events (AE), Symptoms Assessment in Dry Eye (SANDE) scale, ocular surface staining and Schirmer test.
Of 40 included patients, 39 completed the trial. Both tested rhNGF eye drop concentrations were safe and well tolerated. Twenty-nine patients experienced at least one AE (14 in G1 and 15 in G2), of which 11 had at least 1 related AE (8 in G1 and 3 in G2). Both frequency and severity of DED symptoms and ocular surface damage showed significant improvement in both groups, while tear function improved only in G1.
The data of this study indicate that rhNGF eye drops in both doses is safe and effective in improving symptoms and signs of DED. Randomised clinical trials are ongoing to confirm the therapeutic benefit of rhNGF in DED.
NCT02101281.
干眼症（DED）影响超过 14%的老年人群，导致生活质量下降、成本高和视力受损。目前针对 DED 的治疗方法旨在润滑和控制眼表面的炎症。正在寻求针对不同发病机制的新型治疗方法。本研究旨在评估重组人神经生长因子（rhNGF）滴眼液治疗 DED 患者的安全性和疗效。
40 例中重度 DED 患者连续纳入一项 IIa 期、前瞻性、开放标签、多剂量、临床试验，接受 20μg/mL（G1 组）或 4μg/mL（G2 组）rhNGF 滴眼液，每天两次，双眼共 28 天（NCT02101281）。主要结局测量指标为治疗后出现的不良事件（AE）、干眼症状评估（SANDE）量表、眼表面染色和泪液分泌试验。
40 例纳入患者中，39 例完成试验。两种测试浓度的 rhNGF 滴眼液均安全且耐受良好。29 例患者出现至少 1 次 AE（G1 组 14 例，G2 组 15 例），其中 11 例至少有 1 例相关 AE（G1 组 8 例，G2 组 3 例）。两组 DED 症状和眼表面损伤的严重程度均明显改善，而泪液功能仅在 G1 组改善。
本研究数据表明，两种剂量的 rhNGF 滴眼液均安全有效，可改善 DED 的症状和体征。正在进行随机临床试验以确认 rhNGF 在 DED 中的治疗益处。
NCT02101281。
