Bausch + Lomb’s LUMIFY Preservative Free Meets Primary Endpoint in Phase 3 Trial

博士伦的LUMIFY无防腐剂在第三阶段试验中达到主要终点

July 30, 2025

2025年7月30日

Bausch + Lomb has announced promising results from a Phase 3 clinical trial comparing LUMIFY Preservative Free redness reliever eye drops (brimonidine tartrate ophthalmic solution 0.025%) with the original LUMIFY formulation. The findings, recently published in Ophthalmology and Therapy, demonstrate that the preservative-free formulation is statistically non-inferior to LUMIFY in reducing ocular redness in adults..

博士伦公司宣布了一项三期临床试验的可喜结果，该试验比较了无防腐剂的LUMIFY去红润眼液（酒石酸溴莫尼定眼科溶液0.025%）与原始LUMIFY配方。这些研究结果最近发表在《眼科与治疗》杂志上，表明无防腐剂配方在减轻成人眼部红肿方面统计学上不劣于LUMIFY。

Study Design and Primary Efficacy Endpoint

研究设计和主要疗效终点

The randomized, active-controlled, multicenter study included 380 participants experiencing ocular redness. Each participant received either LUMIFY Preservative Free or the original LUMIFY eye drops, administered four times daily for four weeks. The primary efficacy endpoint was the investigator-assessed ocular redness score at eight timepoints ranging from 5 to 240 minutes after administration on Day 1..

这项随机、活性对照、多中心研究包括380名眼部发红的参与者。每位参与者每天使用四次LUMIFY无防腐剂滴眼液或原始LUMIFY滴眼液，持续四周。主要疗效终点是研究者在第1天给药后5至240分钟内八个时间点评估的眼部发红评分。

The study successfully met its primary objective, showing that LUMIFY Preservative Free reduces redness comparably to the original LUMIFY formulation. Additional data from 11 timepoints (1 to 480 minutes) further supported this conclusion.

该研究成功达到了其主要目的，显示出无防腐剂的LUMIFY与原来的LUMIFY配方在减轻红肿方面效果相当。来自11个时间点（1到480分钟）的更多数据进一步支持了这一结论。

Safety Profile and Patient Experience

安全性概况与患者体验

The secondary objective of the study focused on safety, and results confirmed that LUMIFY Preservative Free has a favorable safety profile, comparable to the original product. No significant safety concerns were reported, with low rates of adverse events. Rebound redness occurred in 1.8% of the preservative-free group and 0.6% in the LUMIFY group..

这项研究的次要目标集中在安全性上，结果证实LUMIFY无防腐剂配方具有良好的安全性，与原产品相当。没有报告显著的安全性问题，不良事件发生率较低。无防腐剂组中有1.8%出现反弹性红肿，而LUMIFY组为0.6%。

Patient compliance remained high in both arms of the study (96.8% in the preservative-free group and 97.9% in the LUMIFY group). When asked to describe the drops, participants rated them as “comfortable” (50% vs. 51.1%), “refreshing” (20.2% vs. 20%), and “cool” (14.4% vs. 11.6%) in the preservative-free and original groups, respectively..

研究的两个组中患者依从性仍然很高（无防腐剂组为96.8%，LUMIFY组为97.9%）。当被要求描述滴眼液时，参与者分别对无防腐剂组和原版组评价为“舒适”（50% vs. 51.1%）、“清爽”（20.2% vs. 20%）和“清凉”（14.4% vs. 11.6%）。

Clinical Perspectives and Limitations

临床视角与局限性

Dr. John Ferris, President of Consumer at Bausch + Lomb, stated,

博士伦消费者部门总裁约翰·费里斯 (John Ferris) 表示，

'This study demonstrates that our new LUMIFY Preservative Free eye drops reduce redness quickly and are just as safe and effective as the original LUMIFY, providing a needed option for patients with eye sensitivities.'

“这项研究表明，我们的新型LUMIFY无防腐剂眼药水能快速减轻红肿，并且与原来的LUMIFY一样安全有效，为眼部敏感患者提供了必要的选择。”

The study lead Dr. Melissa Toyos of Toyos Clinic, added:

该研究的负责人、Toyos诊所的梅丽莎·托约斯博士补充道：

'The results show that LUMIFY Preservative Free is a well-tolerated alternative for consumers with ocular redness who have sensitivities to preservatives or are at increased risk of ocular surface disease.'

“结果表明，LUMIFY无防腐剂是眼部发红且对防腐剂敏感或有较高眼部表面疾病风险的消费者的一种良好耐受性替代品。”

The authors noted limitations of the study, including the lack of statistical inference for all secondary outcomes due to the hierarchical analysis plan. They emphasized that baseline dry eye severity and lubricating drop usage could have impacted both tolerability and response assessments. Further studies investigating long-term effects and post-treatment follow-ups beyond 7 days were recommended..

作者指出了研究的局限性，包括由于分层分析计划，所有次要结局缺乏统计推断。他们强调，基线干眼严重程度和润滑滴眼液的使用可能影响了耐受性和反应评估。建议进一步研究调查长期效果和超过7天的治疗后随访。

Reference:

参考：

Toyos M, DiVito M, Messmer EM, et al. A multicenter randomized double-masked study comparing preservative-free brimonidine tartrate ophthalmic solution 0.025% with LUMIFY 0.025% for ocular redness in adults. Ophthalmol Ther. 2025. https://doi.org/10.1007/s40123-025-01194-z

Toyos M, DiVito M, Messmer EM, 等。一项多中心随机双盲研究，比较0.025%无防腐剂酒石酸溴莫尼定滴眼液与0.025% LUMIFY在成人眼部充血中的效果。《眼科治疗学》。2025年。https://doi.org/10.1007/s40123-025-01194-z