Chiambaretta Frédéric, Doan Serge, Labetoulle Marc, Rocher Nicolas, Fekih Lamia El, Messaoud Riadh, Khairallah Moncef, Baudouin Christophe
CHU Gabriel-Montpied, Clermont-Ferrand - France.
Bichat Hospital, Paris - France.
Eur J Ophthalmol. 2017 Jan 19;27(1):1-9. doi: 10.5301/ejo.5000836. Epub 2016 Jul 20.
This study compared the efficacy and safety of hyaluronic acid (HA)-trehalose, a new eyedrop containing trehalose (a natural bioprotectant) and HA, to an established formulation containing only HA.
This was a phase III, randomized, active-controlled, investigator-masked, multicenter study in France and Tunisia. In all, 105 adult patients (≥18 years) with moderate to severe dry eye disease (DED) received either HA-trehalose (n = 52) or HA (n = 53) 3-6 times per day for 84 days. The primary efficacy variable was the Oxford grading score at day 35. A questionnaire on dry eye and symptoms, Schirmer test, tear break-up time, conjunctival hyperemia, and global performance were assessed as secondary efficacy criteria at baseline, day 35, and day 84. Safety assessments were standard.
Noninferiority of HA-trehalose to HA for keratoconjunctivitis sicca assessed by Oxford grading score was demonstrated at day 35. For the secondary efficacy parameters, reductions in dry eye questionnaire classes of none or mild at day 84, dry eye symptoms of stinging, itching, and blurred vision at day 35, and investigator (days 35 and 84) and patient assessments (day 35) of global performance were significantly better for HA-trehalose. There were no clinically meaningful differences between groups for the other secondary criteria. Both treatments were well-tolerated, and there were fewer ocular symptoms upon instillation and fewer adverse events for HA-trehalose than for HA.
Hyaluronic acid-trehalose is effective and safe, with better patient satisfaction, than existing HA-only eyedrops particularly from the first month of treatment, and offers a therapeutic advancement in the treatment of moderate to severe DED.
本研究比较了透明质酸（HA）-海藻糖（一种含有海藻糖（天然生物保护剂）和HA的新型滴眼液）与仅含HA的已确立配方的疗效和安全性。
这是一项在法国和突尼斯进行的III期、随机、活性对照、研究者设盲、多中心研究。共有105例年龄≥18岁的中重度干眼病（DED）成年患者，每天接受3 - 6次HA-海藻糖（n = 52）或HA（n = 53）治疗，持续84天。主要疗效变量是第35天的牛津分级评分。在基线、第35天和第84天，评估干眼及症状问卷、泪液分泌试验、泪膜破裂时间、结膜充血和整体表现作为次要疗效标准。安全性评估为标准评估。
在第35天，通过牛津分级评分评估，HA-海藻糖在治疗干眼症方面不劣于HA。对于次要疗效参数，HA-海藻糖在第84天干眼问卷中无或轻度等级的减少、第35天干眼症状刺痛、瘙痒和视力模糊的减轻，以及研究者（第35天和第84天）和患者评估（第35天）的整体表现方面显著更好。两组在其他次要标准方面无临床意义上的差异。两种治疗耐受性良好，与HA相比，HA-海藻糖滴入时眼部症状更少，不良事件也更少。
透明质酸-海藻糖有效且安全，与现有的仅含HA的滴眼液相比，患者满意度更高，尤其是在治疗的第一个月，并且在中重度DED的治疗中提供了治疗进展。
