臨床研究等提出・公開システム

Scientific Title	ROH-101 phase 3 study - uncontrolled open-label study in patients with cytomegalovirus corneal endotheliitis -
Public Title	ROH-101 phase 3 study - uncontrolled open-label study in patients with cytomegalovirus corneal endotheliitis -

Contact for Scientific Queries	Name	Kitano Takashi
	Affiliation	Rohto Pharmaceutical Co.,Ltd.
	Address	1-8-1 Tatuminishi, Ikuno, Osaka
	Telephone	+81-6-6758-6925
	E-mail	rohtocl@rohto.co.jp
Contact for Public Queries	Name	Kitano Takashi
	Affiliation	Rohto Pharmaceutical Co.,Ltd.
	Address	1-8-1 Tatuminishi, Ikuno, Osaka
	Telephone	+81-6-6758-6925
	E-mail	rohtocl@rohto.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Aug. 02, 2021
Actual date of first enrollment
Target sample size		12
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients who diagnose as CMV endotheliitis based on the clinical manifestations of (1) or (2). (1) Patients who show coin-shaped lesions or linear keratic precipitates (KPs). (2) Patients who show other KPs combined with more than 2 of following signs; anterior uveitis, ocular hypertension and corneal endothelial cell loss. 2) Patients who are CMV DNA positive by examination of qualitative PCR of aqueous humor.
	Exclusion Criteria	1) Patients who are HSV or VZV positive by examination of qualitative PCR of aqueous humor.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		cytomegalovirus corneal endotheliitis
Intervention(s)		One drop of ROH-101(0.15%) 5 times a day for 12 weeks
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		The percentage of patients who achieved <1000 copies /ml(detected limit) in aqueous humor Real-time PCR
Secondary Outcome(s)

Primary Sponsor	Rohto Pharmaceutical Co.,Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	University Hospital Kyoto Prefectural University of Medicine IRB
Address	465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ku Kyoto 602-8566, Japan, Kyoto
Telephone	+81-75-251-5111
E-Mail
Approval Status	Approval
Date of approval	April. 08, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history