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

JRCT ID: jRCT2031220497

Registered date:15/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Dry Eye Disease
• Date of first enrollment: 19/01/2023
• Target sample size: 498
• Study type: Interventional
• Intervention(s): Administer SJP-0132 or Placebo as an eye drop to participants with dry eye disease

Outcome(s)

• Primary Outcome: Change from baseline in dry eye symptoms

Secondary Outcome

- Dry eye signs and symptoms
- Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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

Exclude criteria

- 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

Related Information

• Primary Sponsor: Omatsu Kazunori