Active-Controlled, Parallel-Group Study of SJP-0135 in Patients with Primary Open Angle Glaucoma or Ocular Hypertension

JRCT ID: jRCT2031230312

Registered date:14/09/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Primary open angle glaucoma or Ocular hypertension
• Date of first enrollment: 15/09/2023
• Target sample size: 140
• Study type: Interventional
• Intervention(s): Eye administration of SJP-0135 or brimonidine tartrate/ timolol maleate combination ophthalmic solution

Outcome(s)

• Primary Outcome: Efficacy
• Secondary Outcome: Efficacy and safety

Key inclusion & exclusion criteria

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

Include criteria

-Aged 18 years or older at the time of Informed Consent (any gender)
-Have been diagnosed with primary open angle glaucoma or ocular hypertension
-Meet the other protocol-specified inclusion criteria

Exclude criteria

-Have a history of, or scheduled ocular surgery/laser therapy during the study
-Unable to discontinue wearing contact lens during the study
-Have active ocular disease other than primary open angle glaucoma or ocular hypertension
-Have severe visual field disorders
-Have abnormalities that interfere with measurement of intraocular pressure
-Have severe systemic illness
-Have a history of hypersensitivity or serious adverse reaction to any of the drugs used in the study
-Pregnant, lactating, or potentially pregnant
-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