Bausch + Lomb Corporation has published results from a phase III 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.
In the randomized, active-controlled, multi-center 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 time points 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; 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.
