Bausch + Lomb Corporation announced Ophthalmology and Therapy has published results from a phase 3 study which assessed the efficacy and safety of LUMIFY Preservative Free redness reliever eye drops compared to LUMIFY redness reliever eye drops for reducing ocular redness.
“Since launching in 2018, LUMIFY has been the No. 1 doctor-recommended redness reliever brand, known for delivering noticeable results in one minute and lasting up to eight hours,”1 said John Ferris, president, Consumer, Bausch + Lomb. “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.”
Phase 3 Study Confirms Non-Inferiority and Safety Profile
In the randomized, active-controlled, multicenter study, 380 participants with ocular redness received either LUMIFY Preservative Free or LUMIFY, administered as a single drop four times daily for four weeks. The primary objective was to demonstrate that LUMIFY Preservative Free is non-inferior to LUMIFY in reducing ocular redness. The primary efficacy endpoint was investigator-assessed ocular redness score at eight timepoints from five-minutes to 240-minutes after drop administration on day one. The secondary objective of the study was to compare the safety of LUMIFY Preservative Free and LUMIFY.
The study met its primary objective, confirming that LUMIFY Preservative Free is statistically non-inferior to LUMIFY in reducing ocular redness in adults. A day one analysis of all 11 time points (one minute to 480 minutes post-administration) further supported these findings; and additional secondary efficacy endpoint data from one minute, 360 minutes and 480 minutes post-administration demonstrated that LUMIFY Preservative Free performs similarly to LUMIFY. The overall safety profile of LUMIFY Preservative Free was favorable and comparable to LUMIFY, and the occurrence of ocular treatment-emergent adverse events was similar in both treatment groups. In this clinical trial, LUMIFY Preservative Free demonstrated to have a low incidence of side effects, like rebound redness and loss of efficacy over time, when used as directed.
“The results show that LUMIFY Preservative Free is a well-tolerated alternative option for consumers with ocular redness who have sensitivities to preservatives or are at increased risk of ocular surface disease,” said Melissa Toyos, MD, and partner, Toyos Clinic, Nashville, TN.
For more information on LUMIFY Preservative Free, visit www.lumifyeyes.com.
References
- IQVIA, Average Share of Weekly Doctor Recommendations, Jan – Dec 2024.