Bausch + Lomb announced Ophthalmology and Therapy has published results from a phase 3 study that assessed the efficacy and safety of Lumify Preservative Free redness reliever eye drops compared to Lumify redness reliever eye drops for reducing ocular redness.

According to a company press release, in the randomized, active-controlled, multicenter study, 380 participants with ocular redness received either Lumify Preservative Free or Lumify, administered as a single drop 4 times daily for 4 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 8t timepoints from 5-minutes to 240-minutes after drop administration on day 1. 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, Bausch + Lomb said in the press release. A day 1 analysis of all 11 time points (1 minute to 480 minutes post-administration) further supported these findings; and additional secondary efficacy endpoint data from 1 minute, 360 minutes and 480 minutes post-administration demonstrated that Lumify Preservative Free performs similarly to Lumify.

According to Bausch + Lomb, 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 company said.