UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The prospective research of the effect of topical ripasudil for pterigyum
Title of the study (Brief title)	The effect of topical ripasudil for pterygium
Region	Japan

Condition
Condition	Pterygium
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of topical ripasudil for pterygium prospectively.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We capture the image of anterior segment of eyes and evaluate the time-dependent change of the area of pterygium.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	0.4% ripasudil is instilled for treatment group twice a day (morning and evening). Instillation is continued for six months.
Interventions/Control_2	No treatment.
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) Pterygium does not regress spontaneously during observation period for two months. 2) The edge of pterygium is smaller than two thirds of corneal radius. 3) A person is more than 20 years old. 4) The consent of the document is obtained.
Key exclusion criteria	1) Persons who are contraindicated for the test drugs. 2) Persons who are allergic to ripasudil. 3) Persons who had severe corneal, conjunctival and intraocular disease. 4) Persons who are thought as inappropriate by principal or subprincipal doctors.
Target sample size	80

Research contact person
Name of lead principal investigator	Miyata Kazunori
Organization	Miyata Eye Hospital
Division name	Ophthalmology
Address	6-3 Kurahara, Miyakonojyo, Miyazaki, 885-0051, Japan
TEL	0986-22-1441
Email	miyata@miyata-med.ne.jp

Public contact
Name of contact person	Ono Takashi
Organization	Miyata Eye Hospital
Division name	Ophthalmology
Address	6-3 Kurahara, Miyakonojyo, Miyazaki, 885-0051, Japan
TEL	0986-22-1441
Homepage URL
Email	ono@miyata-med.ne.jp

Sponsor
Institute	Miyata Eye Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 12 Day
Anticipated trial start date	2017 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 28 Day
Last modified on	2019 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031534