Lifitegrast clinical efficacy for treatment of signs and symptoms of dry eye disease across three randomized controlled trials

Objective: Report efficacy findings from three clinical trials (one phase 2 and two phase 3 [OPUS-1, OPUS-2]) of lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease (DED).

Research design and methods: Three 84-day, randomized, double-masked, placebo-controlled trials. Adults (≥18 years) with DED were randomized (1:1) to lifitegrast 5.0% or matching placebo. Changes from baseline to day 84 in signs and symptoms of DED were analyzed.

Main outcome measures: Phase 2, pre-specified endpoint: inferior corneal staining score (ICSS; 0–4); OPUS-1, coprimary endpoints: ICSS and visual-related function subscale (0–4 scale); OPUS-2, coprimary endpoints: ICSS and eye dryness score (EDS, VAS; 0–100).

Results: Fifty-eight participants were randomized to lifitegrast 5.0% and 58 to placebo in the phase 2 trial; 293 to lifitegrast and 295 to placebo in OPUS-1; 358 to lifitegrast and 360 to placebo in OPUS-2. In participants with mild-to-moderate baseline DED symptomatology, lifitegrast improved ICSS versus placebo in the phase 2 study (treatment effect, 0.35; 95% CI, 0.05–0.65; p?=?0.0209) and OPUS-1 (effect, 0.24; 95% CI, 0.10–0.38; p?=?0.0007). Among more symptomatic participants (baseline EDS ≥40, recent artificial tear use), lifitegrast improved EDS versus placebo in a post hoc analysis of OPUS-1 (effect, 13.34; 95% CI, 2.35–24.33; nominal p?=?0.0178) and in OPUS-2 (effect, 12.61; 95% CI, 8.51–16.70; p?<?0.0001).

Limitations: Trials were conducted over 12 weeks; efficacy beyond this period was not assessed.

Conclusions: Across three trials, lifitegrast improved ICSS in participants with mild-to-moderate baseline symptomatology in two studies, and EDS in participants with moderate-to-severe baseline symptomatology in two studies. Based on the overall findings from these trials, lifitegrast shows promise as a new treatment option for signs and symptoms of DED.     

Study of Laser Ocular Effect and Damage

In this paper, the characteristics and regularities of acute ocular injuries by direct laser exposure are briefly reviewed, typical cases of ocular injuries from accidental laser exposure are reported, and laser occupational harm to the eye are discussed on the basis of epidemic investigation of personnel engaged in laser work.     

兔眼眶植入羟基磷灰石义眼台血管化的MRI评价

目的用MRI研究兔眼眶内植入羟基磷灰石（hydroxyapatite，HA）义眼台血管化过程，探讨义眼台血管化MRI表现和特点。方法12只新西兰白兔眼眶内植入直径12mmHA义眼台，于术后第2、3、4、5、6周对所有手术兔行双眼MR平扫及钆喷替酸葡甲胺（Gd-DTPA）增强扫描，计算义眼台强化区体积与义眼台体积比值（VE／VHA），对结果用单因素方差分析。并于第2、4周采用随机数字法抽取2只，第6周对剩余动物义眼台行组织病理学检查。结果术后第2、3、4、5、6周VE／VHA值分别为0．570±0．055；0．787±0．036；0．995±0．014；1．000±0．000；1．000±0．000。第2、3、4周VE／VHA值逐渐增加，均数间比较差异有统计学意义（F=233．094，P=0），第4、5、6周均数间比较差异无统计学意义（F=0．686，P=0．520）。术后2周病理显示义眼台周边有纤维血管生长，第4、6周整个义眼台完全血管化。结论MRI可直观、准确地评价义眼台血管化的程度和范围。     

脉络膜挫伤

回顾６４例外伤性脉络膜挫伤。多发于２０－３０岁的青年男性；最常见有拳击伤；临床主要表现为视力下降，眼底可见脉络膜出血灶及裂伤口，荧光眼底血和造影可帮助诊断。脉络膜挫伤多发生于黄斑部，其次为视乳头周围，多为单个，１－ＰＤ大小，脉络膜破裂的形态多为长弧形，脉络膜出血多为圆形；脉络膜破裂与出血常同时出现。     

环丙沙星滴眼剂在家兔眼内组织分布及其药物动力学

环丙沙星（ｃｉｐｒｏｆｌｏｘａｃｉｎ，ＣＰＦＸ）滴眼液点入兔眼后，用ＨＰＬＣ法测定眼内各组织中药物浓度。结果在角膜、房水、虹膜－睫状体、晶体、玻璃体内峰浓度值分别为１９．４３μｇ／ｇ，１．５８μｇ／ｍｌ，１６．６８μｇ／ｇ，１．４２μｇ／ｇ和０．９６μｇ／ｍｌ；其半衰期分别为０．７６，０．６９，０．９２，０．６１和１．４０ｈ。结果表明ＣＰＦＸ能在眼内达到较高的抗菌浓度。     

GABAergic and glycinergic inputs to the rabbit oculomotor nucleus with special emphasis on the medial rectus subdivision

Contradictory results have been reported about the inhibitory input to the medial rectus subdivision of the oculomotor nucleus of the cat. In the present ultrastructural study, we quantified the GABAergic and glycinergic terminals in the various subdivisions of the rabbit oculomotor nucleus with the use of post-embedding immunocytochemistry combined with retrograde tracing of horseradish peroxidase. The density of the GABAergic input to the medial rectus subdivision was as substantial as that to the other subdivisions and the postsynaptic distribution of the GABAergic and glycinergic innervation did not differ among the different oculomotor subdivisions.     

眶骨延长术治疗眼球突出的实验研究

目的探讨眶骨延长术扩大眶容积治疗眼球突出的可行性。方法1年龄山羊6只,环行截开右侧眶壁,于眶上壁放置延长器,侧向延长1.5cm,经大体、X线、干骨标本及组织学观察成骨情况。结果6只山羊眶骨得到不同程度的侧向延长,延长侧随着眶骨容量的增加,眼球突度较自身对照侧为小。结论眶骨延长术可造成山羊眶骨侧向移位,有可能成为治疗眼球过度突出的方法之一。     

急性重度眼烧伤135例临床分析

目的了解急性重度眼烧伤的临床特点、预后及并发症发生情况。方法对笔者单位病案室保存的1977--2002年住院眼烧伤患者135例（155只眼）的病历进行回顾性统计分析。分析不同深度、原因眼烧伤的眼表修复率、修复时间、致盲情况及并发症。结果治疗后Ⅲ度眼烧伤的修复时间短于Ⅳ度眼烧伤，其修复率也明显高于Ⅳ度眼烧伤（P〈0．01）；在不能修复的Ⅳ度眼烧伤中，酸烧伤致角膜穿孔6只眼，显著高于碱烧伤（1只眼，P〈0．05）。Ⅲ度眼烧伤视力≥0．05者有38只眼，〈0．05者51只眼；Ⅳ度眼烧伤视力≥0．05者0只眼，〈0．05着66只眼。78只酸、碱烧伤眼中，52只眼致盲，致盲率为66．7％；77只热烧伤眼中，65只眼致盲，致盲率为84．4％。Ⅲ度眼烧伤的并发症发生率低于Ⅳ度眼烧伤。其中Ⅲ度眼烧伤角膜穿孔、睑球粘连的发生率（1．1％、36．O％）均显著低于Ⅳ度眼烧伤（27．3％、59．1％，P〈0．01）。在酸烧伤患者中，角膜穿孔及睑外翻的发生率（29．2％、37．5％）较高。而热烧伤患者中眼睑球粘连的发生率（53．2％）较高。结论Ⅳ度眼烧伤伤后的预后差，致盲率高。目前的治疗方法尚不能完全改善其视功能及预后，有待进一步研究。