臨床研究等提出・公開システム

Date of registration	Mar. 16, 2018
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223845

Scientific Title	ST-605 uncontrolled open-label phase 2 study in patients with herpes simplex virus keratitis
Public Title	ST-605 HSV keratitis phase 2 study

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	M's Science Corporation
	Address	info@m-sci.com
	Phone Number
	E-mail Address

Recruitment Status	recruiting

Date of First Enrolment
Target Sample Size		40
Study Type		Interventional
Study Design	Study Design	Uncontrolled, open-label study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients who are diagnosed as HSV epithelial keratitis (dendritic or geographic keratitis) 2) Patients who are 18 years old or more 3) Patients who have informed consent
	Exclusion Criteria
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Herpes simplex virus keratitis
Intervention(s)		investigational material(s) Generic name etc : ST-605 ophthalmic gel INN of investigational material : ganciclovir Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigational material : 1 drop 5 times daily for maximum 3 weeks until healing of keratitis, followed by 3 times daily for a week
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Cure rate after treatment Slit-lamp examination
Secondary Outcome

Primary Sponsor	M's Science Corporation
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-183901
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
3	Dec. 17, 2018	(this page)	Changes
2	Mar. 16, 2018	Detail	Changes
1	Mar. 16, 2018	Detail

List of change history