New research published in Ophthalmology and Therapy demonstrated promising phase 3 data on the safety and efficacy of Bausch + Lomb’s LUMIFY Preservative-Free (PF) redness reliever drops.
This study, take note, was conducted comparing LUMIFY PF to the original LUMIFY redness reliever eye drops for reducing ocular redness.
First up: Familiarize me with LUMIFY.
Bausch + Lomb first introduced the brand in 2018 with those aforementioned (and not PF) LUMIFY drops before expanding in 2023 to include three new specialty eyecare products targeting the sensitive eye area.
Among those new additions: An eye cream, lash and brow serum, and eye makeup remover.
And those original drops?
A few key points to know about them:
- These were the first and only over-the-counter (OTC) eye drops with an FDA-approved formulation of low-dose brimonidine tartrate (0.025%) for treating ocular redness
- To note: Brimonidine is also used to topically reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
- The drops are formulated to relieve “redness of the eye due to minor eye irritations”
- Their efficacy extends to (reportedly):
- Working within 1 minute of topical application
- Lasting up to 8 hours
- This fast-acting mechanism of action was supported in a 2018 phase 3 efficacy study (check out the data highlights)
So how does the PF drop compare to the original?
FDA-approved in April 2024, the updated LUMIFy drops are a replica of the original in efficacy, duration, and intended patient treatment groups—save for the exclusion of preservatives in its formulation as well as its packaging (in single-use vials versus the original drops in a sterile 7.5 mL bottle).
The intent: To selectively target ocular redness in patients with sensitivity to preservatives.
- For a look at its ingredients (inactive included), see here
And as for its dosing schedule: One drop should be instilled into the eye(s) every 6 to 8 hours (and not repeated more than four times per day [QID]).
Alrighty, now to this comparison study.
We’ll start with the basics:
- The design: Randomized, active-controlled, multicenter study (NCT05360784)
- Conducted May to November 2022
- The participants: 380 adult patients presenting with ocular redness (see inclusion criteria)
- The setup: Patients randomized to receive either LUMIFY PF drops or LUMIFY drops as a single drop QID, approximately 4 hours apart
- The duration: up to 4 weeks
And what was measured?
Two main outcomes:
- Primary endpoint: Ocular redness evaluated by investigators at the eight time points following drop administration at visit 1 (day 1)
- 5, 15, 30, 60, 90, 120, 180, and 240 minutes
- In other words: Demonstrating that LUMIFY PF is non-inferior to (working at least as well as) LUMIFY in reducing ocular redness
- Secondary endpoint: Comparing the safety of LUMIFY PF vs LUMIFY
So … what’d they find?
To start, the study met its primary objective in confirming that LUMIFY PF is “statistically non-inferior to LUMIFY in reducing ocular redness" among adult patients.
Specifically: This was observed in a Day 1 analysis of all 11 time points, with efficacy for both formulations noted as early as 1 minute and up to 8 hours after drop instillation.
How about after Day 1?
This similar efficacy continued through Days 14 and 28, with the rebound ocular redness rates for both drops “low and similar” along with a “total clearance of ocular redness and participant-evaluated redness.”
And how did their safety profiles compare?
As with efficacy—similar, or to be more specific: “favorable and comparable.”
- In regards to any potential adverse events (AEs), investigators noted no severe or serious ocular events, while the occurrence of ocular treatment-emergent AEs was “similar in both treatment groups.”
Based on this data, what was the conclusion?
The study authors noted: When used as directed, LUMIFY PF can be considered a well-tolerated, alternative topical solution—”without loss of efficacy or compromised safety”—for patients who prefer a PF-based formulation or are at an increased risk of developing ocular surface disease (OSD).
So with this in mind, how can patients order them?
Click here to purchase the LUMIFY PF drops (and here for the original formulation).