WP-1303 Phase 3 comparison study

JRCT ID: jRCT2080224836

Registered date:20/08/2019

Basic Information

• Recruitment status: terminated
• Health condition(s) or Problem(s) studied: primary open-angle glaucoma, ocular hypertension
• Date of first enrollment: 06/09/2019
• Target sample size: 280
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : WP-1303
INN of investigational material : -
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigational material : agents for ophthalmic use

control material(s)
Generic name etc : Ripasudil hydrochloride hydrate
INN of investigational material : ripasudil
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigational material : agents for ophthalmic use

Outcome(s)

Primary Outcome

safety
efficacy
efficacy:intraocular pressure
safety:adverse event and adverse drug reaction

Secondary Outcome

efficacy
efficacy:intraocular pressure

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients with POAG or OH.
IOP is less than 35mmHg for both eyes.
One eye is greater than or equal to 21mmHg.

Exclude criteria

Patients who have visual acuity of less than 0.3.
Presence of active eye disease (eg., uveitis, ocular infection, severe dry eye).
Pregnant women, lactating women or women who desire to be pregnant.
Patients who is judged inappropriate to participate in the study by investigator or sub-investigator.

Related Information

• Primary Sponsor: Wakamoto pharmaceutical Co., Ltd
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): JapicCTI-194920