UMIN-CTR Clinical Trial

Basic information
Public title	The effect of Rho kinase inhibitor for the treatment of corneal endothelial dysfunction: the 2nd step
Acronym	The effect of Rho kinase inhibitor for the treatment of corneal endothelial dysfunction: the 2nd step
Scientific Title	The effect of Rho kinase inhibitor for the treatment of corneal endothelial dysfunction: the 2nd step
Scientific Title:Acronym	The effect of Rho kinase inhibitor for the treatment of corneal endothelial dysfunction: the 2nd step
Region	Japan

Condition
Condition	Corneal endothelial dysfunction
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of using Rho kinase inhibitor eye drops for the treatment of corneal endothelial dysfunction
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Corneal endothelial cell density
Key secondary outcomes	Visual acuity Corneal thickness Subjective visual function

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of Rho kinase inhibitor eye drops (10mM Y-27632) 4 times daily
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Corneal endothelial cell density is lower than 2000cells/mm2 or not detectable by use of non-contact specular microscopy 2. Existence of visual disturbance or an assumption that visual disturbance will occur due to corneal endothelial dysfunction 3. Obtainment of prior written informed consent
Key exclusion criteria	1. Pregnant or breast-feeding women 2. Patients with a psychological disorder or who could not comprehend instructions from the physician 3. Other criteria deemed improper for inclusion
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shigeru Middle name Last name Kinoshita
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Ophthalmology
Zip code	602-0841
Address	465 Hirokoji Kawaramachi Kamigyo-ku Kyoto, Japan 602-8566
TEL	075-251-5578
Email	nokumura@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Naoki Middle name Last name Okumura
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Ophthalmology
Zip code	602-0841
Address	465 Hirokoji Kawaramachi Kamigyo-ku Kyoto, Japan 602-8566
TEL	075-251-5578
Homepage URL
Email	nokumura@koto.kpu-m.ac.jp

Sponsor
Institute	Department of Ophthalmology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Department of Ophthalmology, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto Prefectural University of Medicine IRB
Address	465 Kajii-cho Kamigyou-ku Kyoto
Tel	075-251-5210
Email	h-hanakura44@mail.pref.kyoto.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	京都府立医科大学附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 17 Day

Related information
URL releasing protocol	NA
Publication of results	Unpublished

Result
URL related to results and publications	NA
Number of participants that the trial has enrolled	20
Results	NA
Results date posted	2020 Year 12 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	NA
Participant flow	NA
Adverse events	NA
Outcome measures	NA
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 03 Month 12 Day
Date of IRB	2010 Year 03 Month 12 Day
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date	2012 Year 01 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 05 Month 17 Day
Last modified on	2020 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004395