Evidence map›Paper›PMID 42824517›Full record

Trial reportClinical ophthalmology (Auckland, N.Z.)2026

Motugivatrep (SJP-0132) 0.3% Ophthalmic Suspension for Dry Eye Disease: A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Trial.

Yuichi Hori, Tomoyuki Wada, Kazunori Omatsu, SJP-0132 Clinical Study Investigators, SJP-0132 Clinical Study Investigators, SJP-0132 Clinical Study Investigators

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In one paragraph

Trial report in Clinical ophthalmology (Auckland, N.Z.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

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

6 authors.

Yuichi HoriDepartment of Ophthalmology, Toho University Faculty of Medicine, Tokyo, Japan.
Tomoyuki WadaSenju Pharmaceuticals Co. Ltd, Osaka, Japan.ORCID 0000-0001-8753-1506
Kazunori OmatsuSenju Pharmaceuticals Co. Ltd, Osaka, Japan.ORCID 0009-0007-1427-9574
SJP-0132 Clinical Study Investigators
SJP-0132 Clinical Study Investigators
SJP-0132 Clinical Study Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To evaluate the efficacy and safety of motugivatrep (SJP-0132) 0.3% ophthalmic suspension, a novel therapy targeting subjective symptoms, in patients with dry eye disease. Patients and Methods: This pivotal, multicenter, randomized, double-masked, placebo-controlled Phase 3 study was conducted in Japan. Outpatients with dry eye-related subjective symptoms and short tear break-up times (TBUT; ≤5 seconds in both eyes) were randomized 1:1 to receive motugivatrep 0.3% ophthalmic suspension or placebo four times daily for 8 weeks. The primary endpoint was the change from baseline in total Dry Eye-related Quality of Life Score (DEQS) at week 4. Results: A total of 535 patients were randomized to motugivatrep 0.3% (n=268) or placebo (n=267). The primary endpoint was met, with a significantly greater improvement in total DEQS at week 4 in the motugivatrep 0.3% group compared with placebo (least-squares mean [LSM] change from baseline -16.76 vs -14.36; LSM difference -2.40; 95% CI -4.72, -0.07; p=0.0433). Consistent improvements in total DEQS were observed with motugivatrep 0.3% vs placebo from week 1 through week 4 (all nominal p<0.05). Motugivatrep 0.3% also demonstrated early improvements in other subjective symptoms, with statistically significant improvements vs placebo in visual analog scale scores for eye dryness at weeks 1 and 4 (both nominal p<0.05).No significant differences were observed between groups in changes in TBUTs or corneal fluorescein staining (CFS) scores overall. A subgroup analysis suggested greater and increasing improvements in total CFS scores with motugivatrep 0.3% compared with placebo in patients with corneal epithelial disorder, indicating potential benefit in this population. Motugivatrep 0.3% was generally well tolerated, with no major safety concerns identified. Conclusion: Motugivatrep 0.3% ophthalmic suspension provided early improvements in subjective symptoms and quality of life and was well tolerated, representing a new therapeutic option for patients with dry eye disease.

Indexed as

DEDDEQSdry eye-related quality of life scoreeye drynesstransient receptor potential cation channel subfamily V member 1 antagonistTRPV1

Identifiers

PMID42824517
PMCPMC13628487

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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.