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SJP-0132 Phase 3 - Multicenter, Randomized, Double-Masked, Placebo Controlled, Parallel-Group Study in Patients with Dry Eye Disease -

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

536

[Sex] Male: 150 participants (28.0%), Female: 386 participants (72.0%) [Mean of age] 50.8 years

[Informed Consent] 704 participants [Randomized and received the investigational product] 535 participants (267 participants in the placebo group and 268 participants in the 0.3% SJP-0132 group) [Completed] 519 participants (259 participants in the placebo group, 260 participants in the 0.3% SJP-0132 group)

Treatment-Emergent Adverse Events (TEAEs) were reported in 92 (17.2%) of 536 participants, including 39 participants (14.6%) in the placebo group and 53 participants (19.7%) in the 0.3% SJP-0132 group. There were no severe TEAEs, serious TEAEs, or TEAEs leading to death. TEAEs leading to treatment discontinuation of the investigational product for treatment period was 1.1% (3 participants) in each treatment group.

<Primary efficacy endpoint> The change from baseline in total Dry Eye-related Quality of life Score (DEQS) at Week 4 showed a greater decrease (improvement) in the 0.3% SJP-0132 group than in the placebo group, and statistically significant differences between the treatment groups were observed. <Secondary efficacy endpoints> The change from baseline in DEQS total score and Visual Analog Scale (VAS) for eye dryness showed greater decreases (improvements) in the 0.3% SJP-0132 group than in the placebo group at all assessment points up to Week 8, and statistically significant differences between the treatment groups were observed in DEQS total score at Week 1, 2, and 4 and in VAS for eye dryness at Week 1 and 4. In other efficacy endpoints for subjective symptoms and objective signs of dry eye, the 0.3% SJP-0132 group generally showed a tendency for improvement greater than that of the placebo group.

When 0.3% SJP-0132 ophthalmic suspension was administered to patients with dry eye disease four times a day for 8 weeks, superiority to placebo was verified for DEQS total score at Week 4, the primary endpoint. There were no severe TEAEs, TEAEs leading to death, or serious TEAEs. In conclusion, the efficacy of 0.3% SJP-0132 ophthalmic suspension in patients with dry eye disease was verified, and it was considered that there was no major safety concern.

April. 30, 2026

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031220497

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. 19, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Aged over 18 years at the time of the informed consent(any gender)
- Live in Japan
- Have continuous subjective symptoms of dry eye disease
- Tear film break-up time of <= 5 seconds
- Meet the other protocol-specified inclusion criteria may apply

- Unable to discontinue wearing contact lens during the study
- 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 - Have a history of, or scheduled ocular surface surgery during the study
- Have ophthalmic disease other than dry eye disease - Have disease that affects subjective symptoms of dry eye - Have known history of hypersensitivity or serious adverse reaction to any of the study drug ingredients - Unable to discontinue any ophthalmic medicines including OTC, except test drug for ophthalmic examination during the study - Female participant who is pregnant, potentially pregnant, lactating or intents to become pregnant. And unable to obtain a consent to practice adequate contraception during the study - Male participant who does not agree to practice adequate contraception and not to donate sperm during the study
- Have judged that it is inappropriate to participate in this study by investigator
- Meet the other protocol-specified exclusion criteria

Both

Dry Eye Disease

Administer SJP-0132 or Placebo as an eye drop to participants with dry eye disease

Change from baseline in dry eye symptoms

- Dry eye signs and symptoms
- Safety

+81-3-5770-1250

Nov. 10, 2022

none