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
{"title":"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。","authors":"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","doi":"10.1177/11206721241266874","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Materials and methods: </strong>This was a randomised, double-blind, multicentre investigation. 96 adults (>18 years of age) with moderate-to-severe DED received Eyestil Plus® (<i>N</i> = 48) or Vismed Multi® (<i>n</i> = 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.</p><p><strong>Results: </strong>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 (<i>p</i>-value = 0.506 and 0.661, respectively), change at 1 and 3 months (<i>p</i>-value = 0.538 and 0.302) for TBUT test; change at 3 months for Schirmer test (<i>p</i>-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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":12000,"journal":{"name":"European Journal of Ophthalmology","volume":" ","pages":"482-491"},"PeriodicalIF":1.4000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A randomised study comparing performance and safety of Eyestil Plus<sup>®</sup> vs Vismed Multi<sup>®</sup> in moderate-to-severe dry eye syndrome patients.\",\"authors\":\"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\",\"doi\":\"10.1177/11206721241266874\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Materials and methods: </strong>This was a randomised, double-blind, multicentre investigation. 96 adults (>18 years of age) with moderate-to-severe DED received Eyestil Plus® (<i>N</i> = 48) or Vismed Multi® (<i>n</i> = 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.</p><p><strong>Results: </strong>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 (<i>p</i>-value = 0.506 and 0.661, respectively), change at 1 and 3 months (<i>p</i>-value = 0.538 and 0.302) for TBUT test; change at 3 months for Schirmer test (<i>p</i>-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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":12000,\"journal\":{\"name\":\"European Journal of Ophthalmology\",\"volume\":\" \",\"pages\":\"482-491\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2025-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Ophthalmology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/11206721241266874\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/8/2 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Ophthalmology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/11206721241266874","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/2 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
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.
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.