臨床研究等提出・公開システム

Date of registration	Dec. 03, 2018
Last modified on	Dec. 25, 2019
Trial ID	jRCT2080224167

Scientific Title	Long-term study on WP-1303 ophthalmic solution in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).
Public Title	WP-1303 Phase III long-term study

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Wakamoto pharmaceutical Co., Ltd
	Address	2-2, Nihonnbashi Honcho 2-chome, Chuo-ku Tokyo
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Wakamoto pharmaceutical Co., Ltd
	Address	2-2, Nihonnbashi Honcho 2-chome, Chuo-ku Tokyo
	Phone Number	+81-3-3279-0370
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		Dec. 07, 2018
Target Sample Size		360
Study Type		Interventional
Study Design	Study Design	multicenter, non-masked, non-comparative
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion 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
	Exclusion 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).
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Japanease patients with POAG, normal-tension glaucoma, exfoliation glaucoma, pigmentary glaucoma or OH
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 : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
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

Primary Sponsor	Wakamoto pharmaceutical Co., Ltd
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Medical Corporation Heishinkai OPHAC Hospital IRB
Address of IRB	4-1-29, Miyahara, Yodogawa-ku, Osaka
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Nov. 23, 2018

Secondary ID No.	JapicCTI-184228
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
3	Dec. 25, 2019	(this page)	Changes
2	Nov. 28, 2019	Detail	Changes
1	Dec. 03, 2018	Detail

List of change history