一项随机研究,比较 Eyestil Plus® 和 Vismed Multi® 在中重度干眼症患者中的性能和安全性。

IF 1.4 4区 医学 Q3 OPHTHALMOLOGY
European Journal of Ophthalmology Pub Date : 2025-03-01 Epub Date: 2024-08-02 DOI:10.1177/11206721241266874
P J Pisella, P Gain, B Cochener, S Baillif, L Kodjikian, C Creuzot-Garcher, D Touboul, M Gonzalvez, P Gabisson, S El Amali, D Galarreta, J Merayo Lloves, A Cano-Ortiz, R Ruiz Mesa, C Civiale, M G Mazzone, J Montero
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引用次数: 0

摘要

目的:这项临床研究比较了 Eyestil Plus® (SIFI)和 Vismed Multi® (TRB Chemedica)在减少中重度干眼症(DED)患者角膜炎病变方面的性能和安全性:这是一项随机、双盲、多中心调查。96名患有中重度干眼症的成年人(18岁以上)接受了Eyestil Plus® (48人)或Vismed Multi® (48人)的治疗,每天6次,为期3个月。1 个月后的主要临床表现为角膜和结膜染色的总体评分。次要目标是 3 个月后的临床表现、泪膜稳定性(泪液破裂时间 (TBUT))、泪液分泌量(Schirmer 测试)、患者报告结果 (PROs)、研究者满意度和安全性:96名参与者被随机分配接受临床研究治疗,其中82.3%为女性,平均年龄为65.8岁。结果表明,Eyestil Plus®治疗中度至重度DED的疗效在1个月后并无劣效。研究目标中的任何一项均未发现统计学差异:1 个月和 3 个月的总体角膜和结膜染色评分变化(p 值分别为 0.506 和 0.661);TBUT 测试 1 个月和 3 个月的变化(p 值分别为 0.538 和 0.302);Schirmer 测试 3 个月的变化(p 值为 0.540)。PROs也没有变化。两种产品的研究者满意度都很高。16.6%的参与者出现了不良反应:这项临床研究表明,在中重度 DED 患者中,Eyestil Plus® 在性能和安全性方面与 Vismed Multi® 相比没有劣势。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A randomised study comparing performance and safety of Eyestil Plus® vs Vismed Multi® in moderate-to-severe dry eye syndrome patients.

Purpose: This clinical investigation compared the performance and safety of Eyestil Plus® (SIFI) and Vismed Multi® (TRB Chemedica) for reducing keratitis lesions in moderate-to-severe dry eye disease (DED) patients.

Materials and methods: This was a randomised, double-blind, multicentre investigation. 96 adults (>18 years of age) with moderate-to-severe DED received Eyestil Plus® (N = 48) or Vismed Multi® (n = 48) 6 times daily for 3 months. The primary objective clinical performance after 1 month as global corneal and conjunctival staining scores. The secondary objectives were clinical performance after 3 months, tear film stability (tear break up time (TBUT), tear production (Schirmer test), patient-reported outcomes (PROs), investigator satisfaction, and safety.

Results: 96 participants were randomised to receive the clinical investigations' treatments, 82.3% of them were female and their mean age was 65.8 years. The non-inferiority of Eyestil Plus® for moderate-to-severe DED was demonstrated at 1 month. No statistical difference was found for any of the study's objectives: change at 1 and 3 months of the global corneal and conjunctival staining score (p-value = 0.506 and 0.661, respectively), change at 1 and 3 months (p-value = 0.538 and 0.302) for TBUT test; change at 3 months for Schirmer test (p-value = 0.540). There were no changes for PROs either. Investigator satisfaction was high for both products. 16.6% of the participants experienced adverse events.

Conclusion: This clinical investigation showed the non-inferiority of Eyestil Plus® compared to Vismed Multi® regarding performance and safety in a moderate-to-severe DED population.

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来源期刊
CiteScore
3.60
自引率
0.00%
发文量
372
审稿时长
3-8 weeks
期刊介绍: The European Journal of Ophthalmology was founded in 1991 and is issued in print bi-monthly. It publishes only peer-reviewed original research reporting clinical observations and laboratory investigations with clinical relevance focusing on new diagnostic and surgical techniques, instrument and therapy updates, results of clinical trials and research findings.
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