Comparative Efficacy of Current Topical Treatments for Dry Eye Disease: A Review of Pivotal Clinical Trials Evaluating Corneal Staining Outcomes.

IF 1.9 4区 医学 Q2 OPHTHALMOLOGY
Ahmad Fahmy, Masih Ahmed, Stephen Pflugfelder, Anara Serikbaeva, Fang-Wei Tsao
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Abstract

Dry eye disease (DED) is a multifactorial disorder characterized by disruption of tear film homeostasis, resulting in ocular surface inflammation and damage. Although several Food and Drug Administration-approved topical treatments are available, direct comparisons of their efficacy and safety are complicated by variability in study designs and corneal staining grading scales. This review systematically evaluates and compares the efficacy and safety of topical therapies approved in the United States, focusing on anti-inflammatory and semi-fluorinated alkane (SFA)-based therapies. A systematic literature review identified 12 randomized controlled trials involving a total of 6,984 patients with varying severity of DED eligible for inclusion, with 8 providing data suitable for quantitative meta-analysis and 5 for exploratory regression analysis. Meta-analysis indicated that cyclosporine 0.1%/SFA showed the most significant early improvement (within ≤4 weeks) in total corneal fluorescein staining, outperforming other treatments. Exploratory regression analysis further supported these findings, demonstrating that cyclosporine 0.1%/SFA had the fastest and most consistent reduction in corneal staining, with the steepest improvement slope and strong predictability (R2 = 0.871). Safety analyses highlighted improved local tolerability for SFA-based therapies compared with traditional anti-inflammatory treatments, notably lower instillation site discomfort for both cyclosporine 0.1%/SFA (2.5%-9.9%) and perfluorohexyloctane (≤1%) vs. other cyclosporine formulations. SFA-based therapies, especially cyclosporine 0.1%/SFA, demostrated robust efficacy in improving signs of DED with superior tolerability profiles compared to traditional anti-inflammatory treatments. These findings support the role in effectively managing ocular surface inflammation and optimizing treatment strategies in DED.

当前干眼病局部治疗的比较疗效:评价角膜染色结果的关键临床试验综述
干眼病(DED)是一种多因素疾病,其特征是泪膜稳态被破坏,导致眼表炎症和损伤。虽然有几种食品和药物管理局批准的局部治疗方法,但由于研究设计和角膜染色分级标准的差异,对其疗效和安全性的直接比较很复杂。本综述系统地评估和比较了在美国批准的局部治疗的疗效和安全性,重点是抗炎和基于半氟化烷烃(SFA)的治疗。通过系统文献综述,共纳入12项随机对照试验,涉及6984例不同严重程度的DED患者,其中8项试验的数据适合定量荟萃分析,5项试验的数据适合探索性回归分析。荟萃分析显示,环孢素0.1%/SFA组在角膜荧光素总染色的早期改善(≤4周)最为显著,优于其他治疗。探索性回归分析进一步支持了这些发现,表明环孢素0.1%/SFA对角膜染色的降低速度最快,一致性最强,改善斜率最大,可预测性强(R2 = 0.871)。安全性分析强调,与传统的抗炎治疗相比,基于SFA的治疗的局部耐受性得到了改善,与其他环孢素制剂相比,环孢素0.1%/SFA(2.5%-9.9%)和全氟己辛烷(≤1%)的注射部位不适明显降低。与传统的抗炎治疗相比,以SFA为基础的治疗,特别是环孢素0.1%/SFA,在改善DED症状方面表现出强大的疗效,并且耐受性更强。这些发现支持了有效管理眼表炎症和优化DED治疗策略的作用。
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来源期刊
CiteScore
4.60
自引率
4.30%
发文量
72
审稿时长
1 months
期刊介绍: Journal of Ocular Pharmacology and Therapeutics is the only peer-reviewed journal that combines the fields of ophthalmology and pharmacology to enable optimal treatment and prevention of ocular diseases and disorders. The Journal delivers the latest discoveries in the pharmacokinetics and pharmacodynamics of therapeutics for the treatment of ophthalmic disorders. Journal of Ocular Pharmacology and Therapeutics coverage includes: Glaucoma Cataracts Retinal degeneration Ocular infection, trauma, and toxicology Ocular drug delivery and biotransformation Ocular pharmacotherapy/clinical trials Ocular inflammatory and immune disorders Gene and cell-based therapies Ocular metabolic disorders Ocular ischemia and blood flow Proliferative disorders of the eye Eyes on Drug Discovery - written by Gary D. Novack, PhD, featuring the latest updates on drug and device pipeline developments as well as policy/regulatory changes by the FDA.
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