臨床研究等提出・公開システム

Date of registration	Aug. 20, 2019
Last modified on	Jan. 10, 2020
Trial ID	jRCT2080224839

Scientific Title	A combination study on WP-1303 or placebo and timolol ophthalmic solution in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH)
Public Title	WP-1303 Phase 3 combination 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	-
	E-mail Address	-

Recruitment Status	terminated

Date of First Enrolment		Sept. 06, 2019
Target Sample Size		180
Study Type		Interventional
Study Design	Study Design	multicenter, randomized, double-masked, parallel-group
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with POAG or OH. IOP is less than 35mmHg for both eyes. IOP aftre timolol treated is greater than or equal 18mmHg.
	Exclusion 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.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		primary open-angle glaucoma, ocular hypertension
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 : placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : agents for ophthalmic use
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety efficacy efficacy:intraocular pressure safety:adverse event and adverse drug reaction
Secondary Outcome		efficacy efficacy:intraocular pressure

Primary Sponsor	Wakamoto pharmaceutical Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Shin-Akasaka Clinic Institutional Review Board
Address of IRB	Roppongi Roa Bldg. 11F, 5-5-1, Roppongi Minato-ku, Tokyo
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	July. 30, 2019

Secondary ID No.	JapicCTI-194923
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
2	Jan. 10, 2020	(this page)	Changes
1	Aug. 29, 2019	Detail

List of change history