The purpose of this pilot trial was to evaluate the efficacy and benefits of a preservative-free cross-linked sodium hyaluronate solution (Lacri +®, MP Labo, France) in 19 privately-owned dogs with dry eye. The animals were administered 2 drops of the tested product in each affected eye, twice a day (BID) for 30 days. Improvement in the global ocular clinical score (sum of the individual scores for conjunctivitis, ocular discharge, eye irritation, and corneal opacity/pigmentation/vascularization, each rated from 0 to 3) was defined as the primary outcome. Besides an improvement in each individual ocular score, tear film quality (Tear Break Up Time, TBUT), dogs’ and owners’ quality of life (QoL), as well as an increase in tear production (Schirmer Tear Test-1, STT1), were considered secondary outcomes. These criteria were assessed on D0, D0 + 15 days, and D0 + 30 days. Finally, a qualitative evaluation of clinical improvement was requested from the owners on D0 + 2, + 15 & + 30 days and from the investigators during the follow-up. The global clinical ocular score as well as the individual conjunctival and irritation scores improved significantly (p < 0.0001) during the pilot trial. The average reduction of the global score reached 30% on D0 + 15 days and 55% on D0 + 30 days compared to D0. Ocular discharge was significantly lower (p = 0.0002) on D0 + 30 days compared to baseline; however corneal opacity did not show any significant changes from D0 to the end of the follow-up period. The quantitative tear production was increased at D + 30 (p < 0.0001), with a significant improvement as soon as 2 weeks in, with around 30% and 60% of dogs presenting an STT1 value above 10 on D0 + 15 days and on D0 + 30 days, respectively. The QoL score was significantly improved compared to D0 at all time points (p < 0.0001). After 2 days of treatment, 39% of the owners rated the efficacy as “good”. The efficacy of the tested product was considered “Good” or “Very Good” by the investigators in 78% and 93% of the cases, on D0 + 15 days and D0 + 30 days, respectively. The tolerance of this preservative-free formulation was good, with only rare and transient minor local reactions, realated to administration rather than the product itself.

中文翻译：

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不含防腐剂的交联透明质酸钠溶液 Lacri +® 对干眼犬的评估：初步试验

该试点试验的目的是评估不含防腐剂的交联透明质酸钠溶液（Lacri +®，MP Labo，法国）对 19 只患有干眼症的私家犬的功效和益处。向动物每只受影响的眼睛滴入 2 滴测试产品，每天两次 (BID)，持续 30 天。总体眼部临床评分（结膜炎、眼部分泌物、眼睛刺激和角膜混浊/色素沉着/血管化的各个评分的总和，每个评分从0到3）的改善被定义为主要结局。除了每个人的眼部评分、泪膜质量（泪膜破裂时间，TBUT）、狗和主人的生活质量（QoL）以及泪液产生量的增加（Schirmer Tear Test-1，STT1）方面都有所改善，被认为是次要结果。这些标准在 D0、D0 + 15 天和 D0 + 30 天进行评估。最后，要求业主在 D0 + 2、+ 15 和 + 30 天以及随访期间的研究人员对临床改善进行定性评估。在试点试验期间，整体临床眼部评分以及个体结膜和刺激评分显着改善（p < 0.0001）。与D0相比，D0+15天的全局得分平均降低了30%，D0+30天的全局得分平均降低了55%。与基线相比，D0 + 30 天时眼部分泌物显着降低 (p = 0.0002)；然而，从 D0 到随访期结束，角膜混浊没有显示出任何显着变化。D + 30 时泪液产量增加（p < 0.0001），两周后就有显着改善，约 30% 和 60% 的狗在 D0 + 15 天和 D0 时的 STT1 值高于 10分别+ 30 天。与 D0 相比，所有时间点的 QoL 评分均显着提高 (p < 0.0001)。治疗2天后，39%的业主评价效果为“好”。在 D0 + 15 天和 D0 + 30 天时，研究人员分别在 78% 和 93% 的病例中认为受测产品的功效为“良好”或“非常好”。这种不含防腐剂的配方的耐受性良好，仅出现罕见且短暂的轻微局部反应，这些反应与给药而非产品本身有关。