LUMIFY Preservative Free Meets Phase 3 Goal

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.

Study Design and Primary Efficacy Endpoint

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.

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.

Safety Profile and Patient Experience

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.

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.

Clinical Perspectives and Limitations

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

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

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.

Reference:

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