Evidence map›Paper›PMID 40711722›Full record

ArticleOphthalmology and therapy2025

A Multicenter Randomized Double-Masked Study Comparing Preservative-free Brimonidine Tartrate Ophthalmic Solution 0.025% with LUMIFY

Melissa Toyos, Melinda DiVito, Elisabeth M Messmer, Selina McGee, Jared Peterson, Assem Patel, Guruprasad Pattar, David G Evans, Patrick M Vollmer, Gina Wesley

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Ophthalmology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05360784 (The Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Preservative-Free Formulation With Lumify® 0.025% in Adult Subjects With Ocular Redness), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05360784 phase3completednot on this map

The Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Preservative-Free Formulation With Lumify® 0.025% in Adult Subjects With Ocular Redness

TypeinterventionalSponsorBausch & Lomb IncorporatedRan2022 to 2022Enrolled380ConditionsOcular RednessArmsBrimonidine tartrate ophthalmic solution 0.025% preservative-free formulation, Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Melissa ToyosToyos Clinic, 4200 Stammer Pl, Memphis, TN, USA. mtoyos@toyosclinic.com.
Melinda DiVitoBausch + Lomb, Bridgewater, NJ, USA.
Elisabeth M MessmerDepartment of Ophthalmology, Ludwig-Maximilian University, Munich, Germany.
Selina McGeeBeSpoke Vision, Edmond, OK, USA.
Jared PetersonMountain View Eye Center, Layton, UT, USA.
Assem PatelVita Eye Clinic, Shelby, NC, USA.
Guruprasad PattarThe Eye Care Institute, Louisville, KY, USA.
David G EvansTotal Eye Care, Memphis, TN, USA.
Patrick M VollmerVita Eye Clinic, Shelby, NC, USA.
Gina WesleyComplete Eye Care of Medina, Hamel, MN, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOcular redness is common, can affect quality of life, and can be relieved by short-term use of topical adrenergic receptor (AR) agonists. Brimonidine tartrate ophthalmic solution 0.025% (LUMIFY

methodsThis randomized, active-controlled, multicenter study aimed to establish non-inferior efficacy of BTOS-PF 0.025% to LUMIFY 0.025% and compare safety. Randomized participants received either formulation instilled as a single drop four times daily, for 4 weeks. The primary endpoint was investigator-assessed ocular redness at 5, 15, 30, 60, 90, 120, 180, and 240 min post-instillation at visit 1 (day 1). Eight hierarchical secondary endpoints included additional post-instillation timepoints at visit 1 and visits 2 and 3 (days 14 and 28), and participant-assessed redness.

resultsBTOS-PF 0.025% was statistically non-inferior to LUMIFY 0.025% for ocular redness reduction across the eight timepoints at visit 1. Efficacy for both formulations was seen as early as 1 min and up to 8 h post-instillation. BTOS-PF 0.025% performed similarly to LUMIFY 0.025% after 14 and 28 days, rebound redness rates were low and similar, and total clearance of ocular redness and participant-evaluated redness were similar. The safety profile of both formulations was similar, with no severe or serious ocular events.

conclusionsBTOS-PF 0.025% was non-inferior to LUMIFY 0.025% in reducing ocular redness in adults, was well-tolerated, and offers an alternative topical solution, without loss of efficacy or compromised safety, for patients who prefer a preservative-free formulation or are at increased risk of OSD. CLINICAL

trial registrationClinicalTrials.gov identifier: NCT05360784. Date of registration: 29 April 2022.

Indexed as

Benzalkonium chlorideBrimonidineBrimonidine tartrate ophthalmic solution 0.025%HyperemiaLUMIFYOcular rednessPatient preferencePreservative-freeVasoconstriction

Identifiers

PMID40711722
PMCPMC12370570

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.