Placebo Controlled Comparative Study of SJP-0130 in Primary Open Angle Glaucoma or Ocular Hypertention patients

JRCT ID: jRCT2031210584

Registered date:07/02/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Glaucoma / Oular hypertension
• Date of first enrollment: 28/02/2022
• Target sample size: 75
• Study type: Interventional
• Intervention(s): Administration of SJP-0130 or placebo

Outcome(s)

• Primary Outcome: Efficacy and safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

- Aged 20 years or older and less than 75 years at the time of the informed consent
- Male or non-childbearing potential female patients
- Have been diagnosed with primary open angle glaucoma or ocular hypertension
- Meet the other protocol-specified inclusion criteria

Exclude criteria

- Received treatment of glaucoma other than eye drops in eye
- Received surgery or laser therapy in eye
- Have ophthalmic disease other than primary open angle glaucoma or ocular hypertention
- Have known history of hypersensitivity or serious adverse reaction to any of the study drug ingredients
- Have advanced visual field disorder
- Have eye abnomalitites that interfere with accurate measurement of ocular pressure
- 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