臨床研究等提出・公開システム

SJP-0132 Phase 3 -Multicenter, Open-label, Long-term Study in Patients with Dry Eye Disease-

Long-term Study of SJP-0132 in Patients with Dry Eye Disease

162

[Sex] Male: 37 participants (22.8%), Female: 125 participants (77.2%) [Mean of age] 55.0 years

[Informed Consent] 183 participants [Received the investigational product] 162 participants (monotherapy of 0.3% SJP-0132: 105 participants, combination therapy with 0.3% SJP-0132 and one of the therapeutic agents for dry eye disease (diquafosol sodium, rebamipide) or keratoconjunctival epithelial disorder]: 57 participants) [Completed] 149 participants (monotherapy: 95 participants, combination therapy: 54 participants)

Treatment-Emergent Adverse Events (TEAEs) were reported in 73 (45.1%) of 162 participants. There were no severe TEAEs and TEAEs leading to death. Serious TEAEs were reported in 1.9% (3 participants), and all of these events were considered not to be the study drug-related TEAEs. TEAEs leading to discontinuation of the investigational product were reported in 1.9% (3 participants). TEAEs with an incidence of 2% or more in overall participants were eye discharge (3.7% [6/162 participants]), conjunctivitis allergic (2.5% [4 participants]), feeling cold (7.4% [12/162 participants]), nasopharyngitis (6.2% [10 participants]), COVID-19 (3.7% [6 participants]), influenza (3.1% [5 participants]), cough (3.1% [5 participants]), and back pain (2.5% [4 participants]). Of these events, eye discharge in 5 participants (3.1%), conjunctivitis allergic in 1 participant (0.6%), feeling cold in 12 participants (7.4%) and cough in 1 participant (0.6%) were considered study drug-related.

[Primary endpoint] Refer to "Adverse events". [Secondary endpoints] The total score of Dry Eye-related Quality of life Score (DEQS) and Visual Analog Scale (VAS) for eye dryness decreased (improved) from baseline to Week 1, the first assessment point, followed by decrease over time to Week 52. Other endpoints also showed a trend toward improvement from baseline.

There were no severe TEAEs or TEAEs leading to death. Serious TEAEs reported were considered unrelated to study drug. Improvements in the subjective symptoms and objective signs of dry eye disease were observed, and the treatment effect was sustained throughout the 52-week period without attenuation. In conclusion, there was no safety concern and the efficacy persisted without reduction when 0.3% SJP-0132 ophthalmic suspension was administered over a long term.

April. 30, 2026

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031220392

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. 12, 2022

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single 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 as an eye drop to participants with dry eye disease

Safety

Dry eye signs and symptoms

+81-3-5770-1250

Oct. 20, 2022

none