Fogt Jennifer S, Kowalski Matthew J, King-Smith P Ewen, Epitropolous Alice T, Hendershot Andrew J, Lembach Carrie, Maszczak John Paul, Jones-Jordan Lisa A, Barr Joseph T
The Ohio State University College of Optometry.
The Ohio State University Department of Ophthalmology, Columbus, OH, USA.
Clin Ophthalmol. 2016 Nov 7;10:2237-2243. doi: 10.2147/OPTH.S120158. eCollection 2016.
The aim of this study was to evaluate the efficacy of a lipid containing emollient eye drop, Soothe XP, which was reformulated in 2014 with a more stable preservative and buffer system, compared to a control, non-emollient, eye drop (Systane Ultra) in improving lipid layer thickness (LLT) in subjects with dry eye due to meibomian gland dysfunction (MGD).
This prospective single-center, open-label, cross-over, examiner masked-study enrolled subjects aged 30-75 years with lipid-deficient dry eye and a clinical diagnosis of MGD as determined by a slit lamp examination, an evaluation of meibomian gland drop out with meibography, and a standard patient evaluation of eye dryness questionnaire of >5. Eligibility was then determined by a LLT of <75 nm at baseline and the inability to increase LLT ≥15 nm with three blinks, as determined by interferometric methods. Subjects were randomized to receive a single emollient or non-emollient eye drop at Visit 1 and were crossed over for the alternate treatment at Visit 2. At each visit, LLT was measured prior to and 15 minutes following the instillation of the assigned eye drop. The primary endpoint was the change in LLT from baseline.
Subjects (n=40) were enrolled and 35 completed the two study arms. Mean (±SD) patient age was 55.7 years (10.9) and 69% were female. Mean (±SD) LLT at baseline was 49.5 nm (9.2). Instillation of Soothe XP resulted in an increase in LLT to 77.5 nm (29.3) 15 minutes following drop instillation, which is an increase of 28.0 nm (27.4) (<0.001). In contrast, LLT 15 minutes after the instillation of Systane Ultra was 50.8 nm (14.1), which was not statistically significant when compared to the baseline LLT.
In this study of subjects with MGD, the emollient, or lipid containing eye drop, increased the LLT of tears when measured 15 minutes after instilling a single eye drop.
本研究旨在评估一种含脂质的润肤眼药水Soothe XP的疗效，该眼药水于2014年重新配方，采用了更稳定的防腐剂和缓冲系统，与对照非润肤眼药水（Systane Ultra）相比，在改善睑板腺功能障碍（MGD）所致干眼症患者的脂质层厚度（LLT）方面的效果。
这项前瞻性单中心、开放标签、交叉、检查者盲法研究纳入了年龄在30 - 75岁之间、患有脂质缺乏性干眼症且经裂隙灯检查、睑板腺造影评估睑板腺缺失以及标准干眼患者评估问卷得分>5确诊为MGD的受试者。通过干涉测量法确定基线时LLT<75 nm且眨眼三次后LLT无法增加≥15 nm的受试者符合入选条件。受试者在第1次就诊时随机接受一种润肤或非润肤眼药水，并在第2次就诊时交叉接受另一种治疗。每次就诊时，在滴入指定眼药水之前和之后15分钟测量LLT。主要终点是LLT相对于基线的变化。
共纳入40名受试者，35名完成了两个研究组。患者平均年龄（±标准差）为55.7岁（10.9），69%为女性。基线时平均（±标准差）LLT为49.5 nm（9.2）。滴入Soothe XP后15分钟，LLT增加至77.5 nm（29.3），增加了28.0 nm（27.4）（P<0.001）。相比之下，滴入Systane Ultra后15分钟的LLT为50.8 nm（14.1），与基线LLT相比无统计学意义。
在这项针对MGD受试者的研究中，单次滴入润肤或含脂质的眼药水后15分钟测量发现，其增加了泪液的LLT。
