Perfluorohexyloctane Eye Drops in Premenopausal and Postmenopausal Women with Dry Eye Disease Associated with Meibomian Gland Dysfunction: A Post Hoc Analysis of a Phase 3 Trial.

IF 2 4区 医学 Q3 OPHTHALMOLOGY
Yihua Zhu, Jing Xie, Xiaoru Shi, Yabin Sun
{"title":"Perfluorohexyloctane Eye Drops in Premenopausal and Postmenopausal Women with Dry Eye Disease Associated with Meibomian Gland Dysfunction: A Post Hoc Analysis of a Phase 3 Trial.","authors":"Yihua Zhu, Jing Xie, Xiaoru Shi, Yabin Sun","doi":"10.1080/02713683.2025.2549289","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Sex hormone changes, often occurring during menopause, are implicated in meibomian gland dysfunction (MGD) and evaporative dry eye disease (DED). This study aimed to evaluate whether menopausal status affects the treatment outcomes of perfluorohexyloctane eye drops.</p><p><strong>Methods: </strong>This post hoc analysis used data from a phase 3 trial (NCT05515471) of perfluorohexyloctane eye drops in patients with DED associated with MGD. The efficacy and safety of perfluorohexyloctane compared with 0.6% saline were evaluated within each menopausal status subgroup (premenopausal or postmenopausal), and the interaction between treatment and menopausal status was assessed.</p><p><strong>Results: </strong>In total, 245 women (94 postmenopausal and 151 premenopausal) were included. In the postmenopausal subgroup, the propensity score weighted least-squares mean differences (LSMD) in changes from baseline to day 57 in total corneal fluorescein staining (tCFS) score and eye dryness score (EDS) between perfluorohexyloctane and saline were -1.0 (95% CI, -2.0, 0.0) and -7.9 (95% CI, -15.6, -0.2), respectively. In the premenopausal subgroup, the propensity score weighted LSMD in changes from baseline to day 57 in tCFS score and EDS were -1.4 (95% CI, -2.3, -0.5) and -14.0 (95% CI, -20.3, -7.8), respectively. Both subgroups showed improvements in some DED symptoms. No statistically significant interaction was observed between menopausal status and treatment across all measured outcomes. Perfluorohexyloctane was well tolerable in both subgroups.</p><p><strong>Conclusions: </strong>Perfluorohexyloctane eye drops improved signs and symptoms of DED associated with MGD and were safe in both postmenopausal and premenopausal women. Further studies are needed to confirm the influence of menopausal status on perfluorohexyloctane efficacy.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05515471.</p>","PeriodicalId":10782,"journal":{"name":"Current Eye Research","volume":" ","pages":"1-7"},"PeriodicalIF":2.0000,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current Eye Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/02713683.2025.2549289","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Purpose: Sex hormone changes, often occurring during menopause, are implicated in meibomian gland dysfunction (MGD) and evaporative dry eye disease (DED). This study aimed to evaluate whether menopausal status affects the treatment outcomes of perfluorohexyloctane eye drops.

Methods: This post hoc analysis used data from a phase 3 trial (NCT05515471) of perfluorohexyloctane eye drops in patients with DED associated with MGD. The efficacy and safety of perfluorohexyloctane compared with 0.6% saline were evaluated within each menopausal status subgroup (premenopausal or postmenopausal), and the interaction between treatment and menopausal status was assessed.

Results: In total, 245 women (94 postmenopausal and 151 premenopausal) were included. In the postmenopausal subgroup, the propensity score weighted least-squares mean differences (LSMD) in changes from baseline to day 57 in total corneal fluorescein staining (tCFS) score and eye dryness score (EDS) between perfluorohexyloctane and saline were -1.0 (95% CI, -2.0, 0.0) and -7.9 (95% CI, -15.6, -0.2), respectively. In the premenopausal subgroup, the propensity score weighted LSMD in changes from baseline to day 57 in tCFS score and EDS were -1.4 (95% CI, -2.3, -0.5) and -14.0 (95% CI, -20.3, -7.8), respectively. Both subgroups showed improvements in some DED symptoms. No statistically significant interaction was observed between menopausal status and treatment across all measured outcomes. Perfluorohexyloctane was well tolerable in both subgroups.

Conclusions: Perfluorohexyloctane eye drops improved signs and symptoms of DED associated with MGD and were safe in both postmenopausal and premenopausal women. Further studies are needed to confirm the influence of menopausal status on perfluorohexyloctane efficacy.

Trial registration: ClinicalTrials.gov identifier, NCT05515471.

全氟己辛滴眼液用于绝经前和绝经后伴有睑板腺功能障碍的干眼病妇女:一项3期试验的事后分析
目的:性激素变化,通常发生在更年期,与睑板腺功能障碍(MGD)和蒸发性干眼病(DED)有关。本研究旨在评估绝经状态是否会影响全氟己烷滴眼液的治疗效果。方法:这项事后分析使用了一项3期试验(NCT05515471)的数据,该试验使用全氟己烷滴眼液治疗伴有MGD的DED患者。在每个绝经状态亚组(绝经前或绝经后)中评估全氟己辛烷与0.6%生理盐水的疗效和安全性,并评估治疗与绝经状态之间的相互作用。结果:共纳入245名妇女(绝经后94名,绝经前151名)。在绝经后亚组中,从基线到第57天,全氟已辛烷和生理盐水的总角膜荧光素染色(tCFS)评分和眼干评分(EDS)的倾向性评分加权最小二乘平均差异(LSMD)分别为-1.0 (95% CI, -2.0, 0.0)和-7.9 (95% CI, -15.6, -0.2)。在绝经前亚组中,倾向评分加权LSMD从基线到第57天的tCFS评分和EDS的变化分别为-1.4 (95% CI, -2.3, -0.5)和-14.0 (95% CI, -20.3, -7.8)。两个亚组的一些DED症状都有所改善。在所有测量结果中,没有观察到绝经状态和治疗之间有统计学意义的相互作用。在两个亚组中全氟己辛烷耐受良好。结论:全氟己辛烷滴眼液改善了与MGD相关的DED的体征和症状,并且对绝经后和绝经前妇女都是安全的。需要进一步的研究来证实绝经状态对全氟己辛烷疗效的影响。试验注册:ClinicalTrials.gov识别码,NCT05515471。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Current Eye Research
Current Eye Research 医学-眼科学
CiteScore
4.60
自引率
0.00%
发文量
163
审稿时长
12 months
期刊介绍: The principal aim of Current Eye Research is to provide rapid publication of full papers, short communications and mini-reviews, all high quality. Current Eye Research publishes articles encompassing all the areas of eye research. Subject areas include the following: clinical research, anatomy, physiology, biophysics, biochemistry, pharmacology, developmental biology, microbiology and immunology.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信