Evidence map›Paper›PMID 42803882›Full record

ArticleOphthalmology and therapy2026

Effect of Reproxalap Treatment on Dry Eye Disease Symptoms: Analysis of Pooled Data From Two Randomized, Vehicle-Controlled, 12-Week Clinical Trials.

John D Sheppard, Kelly Nichols, Christopher E Starr, Amber Lewis, Desiree Owen, Cathy Zhao, Mei Li, Bill Cavanagh, Todd C Brady

2 registry-linked trialsAbstract read
PubMed 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 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT03879863 phase3completednot on this map

The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

TypeinterventionalSponsorAldeyra Therapeutics, Inc.Ran2019 to 2019Enrolled422ConditionsDry EyeArmsReproxalap Ophthalmic Solution (0.25%) QID, Vehicle Ophthalmic Solution QID, Reproxalap Ophthalmic Solution (0.25%) QID to BID, Vehicle Ophthalmic Solution QID to BID
NCT03916042 phase2completednot on this map

A Multi-Center, Phase 2, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% Novel Formulation) Compared to Vehicle in Subjects With Dry Eye Disease

TypeinterventionalSponsorAldeyra Therapeutics, Inc.Ran2019 to 2019Enrolled206ConditionsDry EyeArmsReproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID, Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

John D SheppardVirginia Eye Consultants, Norfolk, VA, USA.
Kelly NicholsUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Christopher E StarrWeill Cornell Medicine, New York-Presbyterian Hospital, New York, NY, USA.
Amber LewisAbbVie Inc., North Chicago, IL, USA.
Desiree OwenAbbVie Inc., North Chicago, IL, USA.
Cathy ZhaoAbbVie Inc., North Chicago, IL, USA.
Mei LiAbbVie 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.ORCID http://orcid.org/0000-0003-3399-4673

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionReproxalap is a novel reactive aldehyde species inhibitor. Pooled data from two clinical trials were used to evaluate effects on symptoms and safety of reproxalap treatment versus vehicle in participants with dry eye disease (DED).

methodsData were pooled from identically designed arms of two 12-week, randomized, vehicle-controlled, double-masked, parallel-group clinical trials comparing topical ophthalmic reproxalap 0.25% with vehicle, each dosed four times daily for 4 weeks then twice daily for 8 weeks, in participants with DED. Symptoms of ocular dryness and ocular discomfort were assessed using a visual analog scale (0-100) in the intent-to-treat ocular dryness (ITTOD) population (prespecified for the symptom primary endpoint analysis in each trial) of participants with a baseline ocular dryness score of ≥ 3 on the Ora Calibra

resultsA total of 417 participants received study treatment (207 reproxalap, 210 vehicle), and 335 participants were included in the ITTOD population (167 reproxalap, 168 vehicle). The mean improvement from baseline in both ocular dryness and ocular discomfort scores was greater with reproxalap than vehicle at each timepoint (nominal p < 0.05). The least-squares mean difference (reproxalap - vehicle) in overall change from baseline from week 1 to week 12 was -8.5 (95% CI -12.6 to -4.5, p < 0.001) for ocular dryness score and -7.7 (95% CI -11.8 to -3.5, p < 0.001) for ocular discomfort score. The most common adverse event was mild instillation site irritation. There were no serious treatment-related adverse events.

conclusionsReproxalap reduced ocular dryness and discomfort symptoms compared with vehicle as soon as week 1, the first post-baseline assessment, and there were no safety concerns. Reproxalap may represent an innovative, rapidly acting therapeutic option for patients with DED.

trial registrationClinicaltrials.gov NCT03916042 and NCT03879863.

Indexed as

Dry eye diseaseEye dropsOcular discomfortOphthalmic solutionRandomized controlled trialReactive aldehyde speciesReproxalapSymptoms

Identifiers

PMID42803882

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.