Evidence map›Paper›PMID 41964731›Full record

ArticleOphthalmology and therapy2026

Phase 3 Randomized Clinical Trial Evaluating the Safety of Reproxalap in Patients With Dry Eye Disease.

Nathan M Radcliffe, John Sheppard, Blake Simmons, Desiree Owen, Ashley Nguyen, Bill Cavanagh, Todd C Brady

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

Article in Ophthalmology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04735393 (A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease), 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.

NCT04735393 phase3completednot on this map

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

TypeinterventionalSponsorAldeyra Therapeutics, Inc.Ran2021 to 2022Enrolled757ConditionsDry Eye DiseaseArmsReproxalap Ophthalmic Solution (0.25%), Placebo Comparator
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

7 authors.

Nathan M RadcliffeMt Sinai School of Medicine, New York, NY, USA.
John SheppardVirginia Eye Consultants, Norfolk, VA, USA.
Blake SimmonsVision Institute, Colorado Springs, CO, USA.
Desiree OwenAbbVie Inc., North Chicago, IL, USA.
Ashley NguyenAbbVie Inc., North Chicago, IL, USA.
Bill CavanaghAldeyra Therapeutics, Inc, 131 Hartwell Avenue, Suite 320, Lexington, MA, 02421, USA.
Todd C BradyAldeyra Therapeutics, Inc, 131 Hartwell Avenue, Suite 320, Lexington, MA, 02421, USA. tbrady@aldeyra.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionReactive aldehyde species (RASP) are proinflammatory molecules that have been implicated in ocular inflammatory diseases, including dry eye disease (DED). Reproxalap is a small molecule RASP inhibitor in development for the treatment of DED. The objective of this clinical trial was to evaluate the long-term safety of reproxalap 0.25% ophthalmic solution compared with vehicle in patients with DED.

methodsThis was a phase 3, multicenter, double-masked, randomized, vehicle-controlled, parallel-group safety clinical trial in patients with DED. Eligible patients were randomized 2:1 to bilateral treatment with reproxalap or vehicle for 6 weeks or 12 months, with the treatment administered four times daily (QID) for the first 4 weeks then twice daily (BID) for either 2 weeks or 11 months. Safety assessments included treatment-emergent adverse events (TEAEs), slit-lamp biomicroscopy, dilated fundoscopy, best-corrected visual acuity (BCVA), intraocular pressure, corneal endothelial cell density, and laboratory assessments. The primary endpoint was the occurrence of treatment-related serious ocular TEAEs.

resultsA total of 757 patients were enrolled and treated with reproxalap (n = 504) or vehicle (n = 253). In the 12-month arms, 111 and 72 patients receiving reproxalap and vehicle, respectively, completed the trial. There were no treatment-related serious TEAEs. The most common TEAE in reproxalap-treated patients was transient, mild, instillation site irritation, most commonly lasting < 1 min. Other ocular TEAEs were similar between reproxalap and vehicle. No safety concerns were identified. Post hoc analysis of BCVA change from baseline in the 12-month safety population showed larger BCVA improvement over 12 months with reproxalap compared with vehicle (p = 0.0185).

conclusionsThe results support the safety of long-term topical reproxalap therapy in patients with DED.

trial registrationClinicalTrials.gov identifier NCT04735393.

Indexed as

Dry eye diseaseEyedropsOphthalmic solutionRandomized controlled trialReactive aldehyde speciesReproxalapSafetyVisual acuity

Identifiers

PMID41964731
PMCPMC13176441

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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.