WP-1303 Phase III long-term study

JRCT ID: jRCT2080224167

Registered date:03/12/2018

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Japanease patients with POAG, normal-tension glaucoma, exfoliation glaucoma, pigmentary glaucoma or OH
• Date of first enrollment: 07/12/2018
• Target sample size: 360
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

Key inclusion & exclusion criteria

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

Include criteria

Each potential subject must satisfy all of the following criteria to be enrolled in the study.
1)Patients with POAG, normal-tension glaucoma, exfoliation glaucoma, pigmentary glaucoma or OH
2)Provision of written voluntary consent to participate in the study
3)Japanease not less than 20 years of age at informed consent
4)IOP at 9 o'clock of IOP confirmation date (-Day 14 to -Day 1) and IOP at 9 o'clock baseline (Day 0) should meet the following criteria:
(1)IOP is less than 35 mmHg for both eyes
(2)IOP at least one eye is not less than 15mmHg and the change from baseline IOP at IOP confirmation date is no more than 3 mmHg

Exclude criteria

Any potential subject who meets any of the following criteria will be excluded from participating in the study.
1)Patients who have visual acuity (corrected visual acuity if correction is necessary) of less than 0.3 in one eye at screening and baseline observation period.
2)Presence of active eye disease (eg., uveitis, ocular infection, severe dry eye).
3)Anticipated use of prohibited drugs between screening and at the completion of treatment phase.
4)Anticipated wear of contact lenses in one eye between screening and at the completion of treatment phase.
5)Presence of uncontrolled systemic disease (eg., hypertension, diabetes).

Related Information

• Primary Sponsor: Wakamoto pharmaceutical Co., Ltd
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): JapicCTI-184228