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SJP-0132 Phase 2 - A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study in Participants with Dry Eye Disease -

Placebo-Controlled, Parallel-Group Study of SJP-0132 in Participants with Dry Eye Disease

344

[Sex] Male: 50 participants (14.5%), Female: 294 participants (85.5%) [Mean of age] 53.6 years

[Informed Consent] 532 participants [Randomized and received the investigational product] 344 participants (85 in the placebo group, 87 in the 0.1% SJP-0132 group, 87 in the 0.3% SJP-0132 group, and 85 in the 1% SJP-0132 groups, hereinafter the same order applies) [Completed] 313 participants (81, 81, 79, and 72)

Among the 344 participants, Treatment-Emergent Adverse Events (TEAEs) were reported in 68, including 15 (17.6%) in the placebo group, 12 (13.8%) in the 0.1% SJP-0132 group, 16 (18.4%) in the 0.3% SJP-0132 group, and 25 (29.4%) in the 1% SJP-0132 groups, respectively. There were no severe TEAEs, serious TEAEs, or TEAEs leading to death in any treatment group. TEAEs leading to discontinuation of the investigational product for the treatment period were reported in 2 participants (2.3%) in the 0.3% SJP-0132 group and 5 participants (5.9%) in the 1% SJP-0132 group, and no participant in the placebo group and the 0.1% SJP-0132 group.

[Primary efficacy endpoint] The change from baseline in corneal fluorescein staining score for all zones at Week 4 showed greater decreases (improvement) in the SJP-0132 groups than in the placebo group, with no statistically significant difference between the 0.1%, 0.3% or 1% SJP-0132 group and the placebo group. [Secondary efficacy endpoints] The change from baseline in total Dry Eye-related Quality of life Score (DEQS) in the 0.3% SJP-0132 group, and in Visual Analog Scale (VAS) for eye dryness in the 0.3% and 1% SJP-0132 groups, were both significantly improved compared with the placebo group at Week 1. In other efficacy endpoints for subjective symptoms and objective signs of dry eye, the SJP-0132 groups generally showed a tendency for improvement greater than that of the placebo group.

As a result of the analysis of the primary efficacy endpoint, all SJP-0132 groups showed greater decreases (improvements) than the placebo group, but no statistically significant differences were observed between the placebo group and the SJP-0132 groups. In the secondary endpoints, the SJP-0132 groups generally showed greater improvements than the placebo group. There were no severe TEAEs, TEAEs leading to death, or serious TEAEs. These results suggested that the optimal clinical dose was 0.3%.

April. 28, 2026

Dec. 04, 2025

https://doi.org/10.1016/j.ajo.2025.11.036

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031200243

Omatsu Kazunori

Senju Pharmaceutical Co., Ltd.

6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo

senju-clinicaltrials@senju.co.jp

Clinical development division

Senju Pharmaceutical Co., Ltd.

6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo

+81-78-777-1018

senju-clinicaltrials@senju.co.jp

Complete

Dec. 24, 2020

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Have a continuous subjective symptoms of Dry Eye Disease
- Tear film break-up time of <= 5 seconds
- Have a fluorescein staining in the cornea
- 20 years and older at the time of Informed Consent

- Contact lens wearers who cannot discontinue the wear over the trial period
- Have clinically active ophthalmic disease other than Dry Eye Disease
- Have a known hypersensitivity or history of serious adverse reaction to any of the study drug ingredients
- Have a history of, or scheduled corneal transplantation during the study
- Have a history of, or scheduled permanent punctal occlusion during the study
- Have used or anticipates use of a punctal plug during the study
- Cannot discontinue any ophthalmic, nasal, or complementary medicines during the study
- Have a history of, or scheduled eye surgery during the study
- Pregnant, potentially pregnant, or lactating

Both

Dry Eye Desease

Administer SJP-0132 or placebo to participants with dry eye disease

Change from baseline in corneal fluorescein staining score

+81-3-5770-1250

Dec. 10, 2020

none