UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical efficacy of FGLM-NH2+SSSR eye drops for intractable corneal epithelial disorders
Title of the study (Brief title)	Clinical efficacy of FGLM-NH2+SSSR eye drops for intractable corneal epithelial disorders
Region	Japan

Condition
Condition	superficial punctate keratopathy persistent epithelial defect
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clinical efficacy of FGLM-NH2+SSSR eye drops for intractable corneal epithelial disorders
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time to complete healing for persistent epithelial defect
Key secondary outcomes	AD classification for SPK

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	FGLM-NH2+SSSR eye drop 4 times a day Until disappearance of the epithelial defect Up to 4 weeks
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	intractable corneal epithelial disorders SPK: superficial punctate keratopathy (SPK) with fluorescein staining by slit-lamp examination PED: the presence of persistent epithelial defect by slit-lamp examination resistant to conventional treatments for more than 1 week
Key exclusion criteria	1. Are pregnant or may possibly be pregnant 2. In breast-feeding women 3. Drug allergies for this agents 4. Were judged an inadequate subject to enrollment by a medical doctor
Target sample size	150

Research contact person
Name of lead principal investigator	Naoyuki Yamada
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	1-1-1 Minami-Kogushi, Ube city, Yamaguchi
TEL	0836-22-2278
Email	n.yamada@po.cc.yamaguchi-u.ac.jp

Public contact
Name of contact person	Naoyuki Yamda
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	1-1-1 Minami-Kogushi, Ube city, Yamaguchi
TEL	0836-22-2278
Homepage URL
Email	n.yamada@po.cc.yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Graduate School of Medicine Department of Ophthalmology
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	山口大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 06 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2006 Year 11 Month 14 Day
Anticipated trial start date	2006 Year 11 Month 14 Day
Last follow-up date	2021 Year 03 Month 31 Day
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 04 Month 05 Day
Last modified on	2017 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030834