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AZR-MD-001 0.5% selenium sulfide ophthalmic ointment for the treatment of contact lens discomfort: A vehicle-controlled, randomized, clinical trial AZR-MD-001 0.5%硫化硒眼膏治疗隐形眼镜不适:一项对照、随机、临床试验。
IF 5.6 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-10-01 DOI: 10.1016/j.jtos.2024.12.009
Fiona Stapleton , Mark Hinds , Jacqueline Tan , Lyndon Jones , Robin Chalmers , Charles Bosworth , Yair Alster

Background

Contact lens discomfort (CLD) is a common problem for CL wearers, and patients with CLD often have changes in meibomian gland function and structure. In a Phase 2 trial AZR-MD-001 0.5% (AZR) ophthalmic ointment improved meibomian gland dysfunction (MGD) in non-lens wearers. The current study evaluated the efficacy and safety of AZR in participants with CLD and concomitant MGD.

Methods

Adults with CLD (Contact Lens Dry Eye Questionnaire-8 >12, range 0–37) and MGD (Meibomian Gland Secretion Score [MGS] ≤12, range 0–45) were randomized (1:1) to AZR:vehicle applied twice-weekly in a three-month multicenter, prospective, double-masked study. Endpoints included difference in change from baseline (CFB) in the number of Meibomian Glands Yielding Liquid Secretion (MGYLS), MGS, the ability to wear their lenses as long as desired, and safety.

Results

At Month 3, AZR (n = 34) significantly increased the MGYLS and MGS versus vehicle (n = 33), with least squares mean difference (LSMD) CFB in MGYLS of 5.0 (SE = 0.47) for AZR and 1.6 (0.45) for vehicle, P < 0.0001; MGS of 13.8 (SE = 0.67) for AZR and 3.8 (SE = 0.68) for vehicle, P < 0.0001. Significantly more participants treated with AZR were able to wear lenses as long as desired (43% vs. 6%, P = 0.0023). The most common treatment-emergent adverse event (TEAE) was eye irritation (61.8% AZR; 0% vehicle). All TEAEs related to treatment were mild/moderate, transient, and did not result in discontinuation.

Conclusion

AZR-MD-001 0.5% significantly improved MGD signs and hours of comfortable CL wear, demonstrating good efficacy, safety, and tolerability in those with CLD.
背景:隐形眼镜不适(CLD)是配戴隐形眼镜的常见问题,患者通常有睑板腺功能和结构的改变。在一项2期试验中,AZR- md -001 0.5% (AZR)眼药膏改善了非晶状体配戴者的睑板腺功能障碍(MGD)。目前的研究评估了AZR对CLD合并MGD患者的疗效和安全性。方法:在一项为期三个月的多中心、前瞻性、双盲研究中,CLD(隐形眼镜干眼症问卷-8 - 12,范围0-37)和MGD(睑板腺分泌评分[MGS]≤12,范围0-45)的成年人随机(1:1)至AZR:每周两次应用载体。终点包括睑板腺分泌液体(MGYLS)数量与基线的变化差异(CFB)、MGS、佩戴隐形眼镜的时间和安全性。结果:在第3个月,AZR (n=34)显著增加了MGYLS和MGS,与对照(n=33)相比,AZR (n=34)的最小二乘平均差(LSMD) CFB在MGYLS中的最小二乘平均差(LSMD)为5.0 (SE = 0.47),对照为1.6(0.45)。结论:AZR- md -001 0.5%显著改善了MGD体征和舒适CL磨损时间,对CLD患者具有良好的疗效、安全性和耐受性。
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引用次数: 0
Pediatric vs adult Stevens Johnson syndrome/toxic epidermal necrolysis: Ocular outcomes and the role of amniotic membrane 儿童vs成人史蒂文斯约翰逊综合征/中毒性表皮坏死松解:眼部结局和羊膜的作用
IF 5.6 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-10-01 DOI: 10.1016/j.jtos.2025.10.008
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引用次数: 0
Re: Significant errors in the paper by Ballesteros-Sánchez A, Rocha-de-Lossada C and Sánchez-González J. Efficacy of eyelid warming devices as first-step treatment in meibomian gland dysfunction: A systematic review with meta-analysis. 2025; 37:33–46 回复:Ballesteros-Sánchez A、Rocha-de-Lossada C和Sánchez-González j的论文存在显著错误。眼睑温热装置作为睑板腺功能障碍第一步治疗的疗效:一项meta分析的系统综述。2025年;37:33-46
IF 5.6 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-10-01 DOI: 10.1016/j.jtos.2025.04.003
Jacqueline Tan
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引用次数: 0
Phenotypic and genotypic profiling of antimicrobial resistance genes and virulence factors in Pseudomonas aeruginosa isolates from keratitis patients 角膜炎患者铜绿假单胞菌耐药基因和毒力因子的表型和基因型分析
IF 5.6 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-10-01 DOI: 10.1016/j.jtos.2025.10.011
Abiye Tigabu , Mark D.P. Willcox , Fiona Stapleton
<div><h3>Background</h3><div><em>Pseudomonas aeruginosa</em> (<em>P. aeruginosa</em>) is a major cause of ocular infections, exhibiting resistance to many antimicrobial agents and the ability to acquire further resistance through mutations and horizontal gene transfer. It employs a range of virulence factors to invade ocular tissues, leading to complications such as corneal scarring and perforation. Alarmingly, multidrug-resistant <em>P. aeruginosa</em> isolates are increasing worldwide. For instance, a recent outbreak in the United States of America (USA) involving an extensively drug-resistant <em>P. aeruginosa</em> PA1270 strain resulted in four deaths, four eye removals, and 14 cases of vision loss. A comprehensive understanding of the antibiotic resistance and virulence mechanisms of <em>P. aeruginosa</em> is essential for the effective management of corneal infections.</div></div><div><h3>Methods</h3><div>Whole-genome sequencing data from 70 <em>P. aeruginosa</em> isolates collected from corneal samples were retrieved from the National Center for Biotechnology Information (NCBI) database and annotated using Prokka 1.14.6. Unique genes identified in these datasets were analyzed against the Comprehensive Antibiotic Resistance Database (CARD) to determine antimicrobial resistance profiles. The presence of acquired resistance genes and virulence factors were assessed using ResFinder and the Virulence Factor Database (VFDB), respectively. Roary v3.13.0 was used for pangenome analysis, while Snippy v4.6.0 was employed for whole-genome variant analysis. Furthermore, mobile genetic elements (MGEs) and pathogenicity islands (PIs) were identified using MobileElementFinder v1.0.3 and IslandViewer 4, respectively. In parallel, phenotypic characterization, including determination of minimum inhibitory concentrations (MICs) for selected antimicrobial agents, was performed using the broth microdilution method. Additionally, a crystal violet assay was conducted to evaluate the biofilm-forming ability of <em>P. aeruginosa</em>.</div></div><div><h3>Results</h3><div>The corneal <em>P. aeruginosa</em> harboured numerous AMR genes against various classes of antibiotics. Notably, the most prevalent acquired resistance genes across all keratitis <em>P. aeruginosa</em> strains were β-lactams <em>blaPAO</em>, and <em>blaOXA</em>, aminoglycoside <em>aph(3′)-IIb</em>, chloramphenicol <em>catB7</em>, and fosfomycin <em>fosA</em>. <em>P. aeruginosa</em> keratitis isolates harbored more core and cloud genes than environmental and cystic fibrosis (CF) strains. A significant difference in ciprofloxacin resistance gene <em>crpP</em> was observed between the keratitis and CF isolates. Additionally, a considerable number of insertion sequences (ISPa1, ISPa6, ISPa32) and transposons (Tn4661, Tn6082, Tn5563) were identified. Phenotypic characterization of antimicrobial resistance (AMR) revealed that gentamicin were the most effective antibiotics against corneal <em>P. aerugino
铜绿假单胞菌(P. aeruginosa)是眼部感染的主要原因,表现出对许多抗微生物药物的耐药性,并能够通过突变和水平基因转移获得进一步的耐药性。它利用一系列毒力因子侵入眼部组织,导致角膜瘢痕和穿孔等并发症。令人震惊的是,耐多药铜绿假单胞菌分离株在世界范围内正在增加。例如,最近在美利坚合众国(美国)爆发了一种广泛耐药的铜绿假单胞菌PA1270菌株,造成4人死亡、4人摘除眼睛和14例视力丧失。全面了解铜绿假单胞菌的抗生素耐药性和毒力机制对于有效管理角膜感染至关重要。方法从美国国家生物技术信息中心(National Center for Biotechnology Information, NCBI)数据库中检索70株铜绿假单胞菌的全基因组测序数据,并使用Prokka 1.14.6进行注释。在这些数据集中鉴定的独特基因与综合抗生素耐药性数据库(CARD)进行分析,以确定抗菌素耐药性谱。分别使用ResFinder和毒力因子数据库(VFDB)评估获得性耐药基因和毒力因子的存在。采用Roary v3.13.0进行全基因组分析,采用Snippy v4.6.0进行全基因组变异分析。此外,利用MobileElementFinder v1.0.3和IslandViewer 4分别鉴定了移动遗传元件(MGEs)和致病岛(pi)。同时,使用肉汤微量稀释法进行表型表征,包括测定所选抗菌药物的最低抑制浓度(mic)。另外,采用结晶紫法对铜绿假单胞菌的生物膜形成能力进行了评价。结果角膜铜绿假单胞菌含有大量抗多种抗生素的AMR基因。值得注意的是,所有铜绿假单胞菌菌株中最常见的获得性耐药基因是β-内酰胺blaPAO和blaOXA、氨基糖苷葡萄球菌(3′)-IIb、氯霉素catB7和磷霉素fosA。铜绿假单胞菌角膜炎分离株比环境性和囊性纤维化(CF)菌株含有更多的核心和云基因。角膜炎与CF分离株环丙沙星耐药基因crpP差异有统计学意义。此外,还鉴定出相当数量的插入序列(ISPa1、ISPa6、ISPa32)和转座子(Tn4661、Tn6082、Tn5563)。结果表明,庆大霉素是抗角膜铜绿假单胞菌最有效的抗生素。68.9%的菌株对亚胺培南有耐药性。令人惊讶的是,26.7%的铜绿假单胞菌菌株被归类为耐多药,它们全部来自印度。此外,61.8%的角膜铜绿假单胞菌分离株是强生物膜产生者,所有耐多药菌株都被鉴定为强生物膜形成者。结论基因型分析揭示了主要的耐药机制,包括抗生素外排、失活和靶点改变,以及多种结构和分泌的毒力因子。虽然在铜绿假单胞菌角膜炎分离株中发现了耐多药和广泛耐药(XDR)菌株,但本研究中的大多数分离株对庆大霉素敏感。这些发现为制定有针对性的治疗策略提供了有价值的见解,当与抗生素联合使用时,可能会改善治疗结果并有助于减轻耐药性的出现。
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引用次数: 0
Response to letter to the editor regarding “Simple limbal epithelial transplantation versus cultivated limbal epithelial transplantation in ocular burns” 回复关于“单纯角膜缘上皮移植与培养角膜缘上皮移植治疗眼部烧伤”的致编辑的信。
IF 5.6 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-10-01 DOI: 10.1016/j.jtos.2025.07.007
Namrata Sharma, Renu Venugopal, Sujata Mohanty, Kamalakannan Priyadarshini, Ritu Nagpal, Deepali Singhal, Aafreen Bari, Tanuj Dada, Prafulla Kumar Maharana, Tushar Agarwal, Ashish Dutt Upadhyay
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引用次数: 0
Ocular manifestations in Stevens‒Johnson syndrome/toxic epidermal necrolysis in cancer patients Stevens-Johnson综合征/肿瘤患者中毒性表皮坏死松解的眼部表现
IF 5.6 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-10-01 DOI: 10.1016/j.jtos.2025.10.010
Jin-Jhe Wang , Chun-Bing Chen , Eugene Yu-Chuan Kang , Wen-Hung Chung , John Wen-Cheng Chang , Kevin Sheng-Kai Ma , Yueh-Ju Tsai , Ming-Tse Kuo , Chi-Chin Sun , Hung-Chi Chen , Shin-Yi Chen , Kuo-Hsuan Hung , Hsin-Yuan Tan , Pier Luigi Surico , David Hui-Kang Ma

Purpose

To evaluate the characteristics, risk factors, and outcomes of ocular involvement in cancer patients with Stevens‒Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), focusing on the role of immune checkpoint inhibitors (ICIs).

Methods

This retrospective case‒control study was conducted at Chang Gung Memorial Hospital, Linkou, Taiwan, between 2004 and 2024. A total of 112 patients with confirmed SJS/TEN and concurrent malignancies were included. The primary outcomes were the prevalence and severity of acute and chronic ocular involvement, assessed using Sotozono's classification. Risk factors for ocular involvement were investigated through univariate and multivariate logistic regression.

Results

Of 112 patients, 46 (41.1 %) developed ocular complications. TEN (adjusted OR, 3.11; 95 % CI, 1.24–7.78; P = 0.02), systemic mucosal involvement (adjusted OR, 4.89; 95 % CI, 1.52–15.80; P = 0.01), and polypharmacy (adjusted OR, 3.52; 95 % CI, 1.36–9.11; P = 0.01) were significant risk factors for ocular involvement. ICI-related SJS/TEN exhibited longer latency (31.0 vs. 13.4 days; P < 0.001) and delayed healing (72.3 vs. 45.8 days; P = 0.002). Chronic ocular complications were more severe in surviving ICI-related patients, as indicated by significantly higher chronic Sotozono scores (7.5 vs. 3.7; P = 0.001), worse dry eye (Schirmer's test 1.8 vs. 3.4 mm; P = 0.01), and poorer visual recovery (0.11 vs. 0.43 logMAR; P = 0.001).

Conclusions

SJS/TEN in cancer patients, particularly those receiving ICIs, is associated with substantial ocular morbidity. The increasing prevalence of ICI-related SJS/TEN emphasizes the need for vigilant ophthalmologic intervention and long-term monitoring.
目的探讨Stevens-Johnson综合征/中毒性表皮坏死松解(SJS/TEN)患者眼部受损伤的特点、危险因素及预后,重点探讨免疫检查点抑制剂(ICIs)的作用。方法回顾性病例对照研究于2004 ~ 2024年在台湾省林口市长庚纪念医院进行。共纳入112例确诊为SJS/TEN并伴有恶性肿瘤的患者。主要结果是急性和慢性眼部受累的患病率和严重程度,使用Sotozono分类进行评估。通过单因素和多因素logistic回归研究眼部受累的危险因素。结果112例患者中有46例(41.1%)出现眼部并发症。TEN(校正OR, 3.11; 95% CI, 1.24-7.78; P = 0.02)、全身粘膜受累(校正OR, 4.89; 95% CI, 1.52-15.80; P = 0.01)和多药(校正OR, 3.52; 95% CI, 1.36-9.11; P = 0.01)是眼部受累的显著危险因素。ici相关的SJS/TEN表现出更长的潜伏期(31.0 vs. 13.4天;P < 0.001)和延迟的愈合(72.3 vs. 45.8天;P = 0.002)。存活的ici相关患者的慢性眼部并发症更为严重,慢性Sotozono评分显著较高(7.5比3.7,P = 0.001),干眼更严重(Schirmer's test 1.8比3.4 mm, P = 0.01),视力恢复较差(0.11比0.43 logMAR, P = 0.001)。结论ssjs /TEN在癌症患者,特别是接受ICIs的患者中,与大量眼部发病率相关。ici相关SJS/TEN患病率的增加强调了警惕的眼科干预和长期监测的必要性。
{"title":"Ocular manifestations in Stevens‒Johnson syndrome/toxic epidermal necrolysis in cancer patients","authors":"Jin-Jhe Wang ,&nbsp;Chun-Bing Chen ,&nbsp;Eugene Yu-Chuan Kang ,&nbsp;Wen-Hung Chung ,&nbsp;John Wen-Cheng Chang ,&nbsp;Kevin Sheng-Kai Ma ,&nbsp;Yueh-Ju Tsai ,&nbsp;Ming-Tse Kuo ,&nbsp;Chi-Chin Sun ,&nbsp;Hung-Chi Chen ,&nbsp;Shin-Yi Chen ,&nbsp;Kuo-Hsuan Hung ,&nbsp;Hsin-Yuan Tan ,&nbsp;Pier Luigi Surico ,&nbsp;David Hui-Kang Ma","doi":"10.1016/j.jtos.2025.10.010","DOIUrl":"10.1016/j.jtos.2025.10.010","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate the characteristics, risk factors, and outcomes of ocular involvement in cancer patients with Stevens‒Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), focusing on the role of immune checkpoint inhibitors (ICIs).</div></div><div><h3>Methods</h3><div>This retrospective case‒control study was conducted at Chang Gung Memorial Hospital, Linkou, Taiwan, between 2004 and 2024. A total of 112 patients with confirmed SJS/TEN and concurrent malignancies were included. The primary outcomes were the prevalence and severity of acute and chronic ocular involvement, assessed using Sotozono's classification. Risk factors for ocular involvement were investigated through univariate and multivariate logistic regression.</div></div><div><h3>Results</h3><div>Of 112 patients, 46 (41.1 %) developed ocular complications. TEN (adjusted OR, 3.11; 95 % CI, 1.24–7.78; P = 0.02), systemic mucosal involvement (adjusted OR, 4.89; 95 % CI, 1.52–15.80; P = 0.01), and polypharmacy (adjusted OR, 3.52; 95 % CI, 1.36–9.11; P = 0.01) were significant risk factors for ocular involvement. ICI-related SJS/TEN exhibited longer latency (31.0 vs. 13.4 days; P &lt; 0.001) and delayed healing (72.3 vs. 45.8 days; P = 0.002). Chronic ocular complications were more severe in surviving ICI-related patients, as indicated by significantly higher chronic Sotozono scores (7.5 vs. 3.7; P = 0.001), worse dry eye (Schirmer's test 1.8 vs. 3.4 mm; P = 0.01), and poorer visual recovery (0.11 vs. 0.43 logMAR; P = 0.001).</div></div><div><h3>Conclusions</h3><div>SJS/TEN in cancer patients, particularly those receiving ICIs, is associated with substantial ocular morbidity. The increasing prevalence of ICI-related SJS/TEN emphasizes the need for vigilant ophthalmologic intervention and long-term monitoring.</div></div>","PeriodicalId":54691,"journal":{"name":"Ocular Surface","volume":"38 ","pages":"Pages 367-376"},"PeriodicalIF":5.6,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145382680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Re: Reply to Prof. Jacqueline Tan's letter. Efficacy of eyelid warming devices as a first-step treatment in meibomian gland dysfunction: A systematic review with meta-analysis. 2025; 37:33-46 眼睑温热装置作为睑板腺功能障碍第一步治疗的疗效:一项系统综述和meta分析。
IF 5.6 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-10-01 DOI: 10.1016/j.jtos.2025.04.002
Ballesteros-Sánchez Antonio, Carlos Rocha-de-Lossada, José-María Sánchez-González
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引用次数: 0
Methodological considerations regarding "Ranking the efficacy of topical treatments for ocular allergy: A network meta-analysis of current evidence" [Letter] 关于“眼部过敏局部治疗的疗效排序:现有证据的网络荟萃分析”的方法学考虑[Letter]
IF 5.6 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-10-01 DOI: 10.1016/j.jtos.2025.10.006
Dror Ben Ephraim Noyman , Michael Mimouni , Ben Klinghoffer
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引用次数: 0
Response to “Methodological considerations regarding 'Ranking the efficacy of topical treatments for ocular allergy: A network meta-analysis of current evidence'” 对“对眼部过敏局部治疗的疗效排序的方法学考虑:对现有证据的网络荟萃分析”的回应
IF 5.6 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-10-01 DOI: 10.1016/j.jtos.2025.10.007
Luksanaporn Krungkraipetch , Taweelarp Tansavadi , Dechathorn Krungkraipetch
{"title":"Response to “Methodological considerations regarding 'Ranking the efficacy of topical treatments for ocular allergy: A network meta-analysis of current evidence'”","authors":"Luksanaporn Krungkraipetch ,&nbsp;Taweelarp Tansavadi ,&nbsp;Dechathorn Krungkraipetch","doi":"10.1016/j.jtos.2025.10.007","DOIUrl":"10.1016/j.jtos.2025.10.007","url":null,"abstract":"","PeriodicalId":54691,"journal":{"name":"Ocular Surface","volume":"38 ","pages":"Pages 390-391"},"PeriodicalIF":5.6,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145382674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
In memoriam: Professor Maurizio Rolando (1950–2025) 纪念:毛里齐奥·罗兰多教授(1950 - 2025)
IF 5.6 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-10-01 DOI: 10.1016/j.jtos.2025.10.003
Stefano Bonini
{"title":"In memoriam: Professor Maurizio Rolando (1950–2025)","authors":"Stefano Bonini","doi":"10.1016/j.jtos.2025.10.003","DOIUrl":"10.1016/j.jtos.2025.10.003","url":null,"abstract":"","PeriodicalId":54691,"journal":{"name":"Ocular Surface","volume":"38 ","pages":"Page 449"},"PeriodicalIF":5.6,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145657307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Ocular Surface
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