UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of fibronectin eye drops on non-healed corneal epithelial disorders
Acronym	The efficacy of fibronectin eye drops
Scientific Title	The efficacy of fibronectin eye drops on non-healed corneal epithelial disorders
Scientific Title:Acronym	The efficacy of fibronectin eye drops
Region	Japan

Condition
Condition	non-healed corneal epithelial disorders
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is well-known that fibronectin facilitates corneal epithelial wound healing. The indication of fibronectin eye drops has been for non-healed epithelial defect, expanded indications have not been evaluated. Thus we are going to evaluate the efficacy of fibronectin eye drops for the purpose to expand the indication of fibronectin eye drops to non-healed corneal epithelial disorders.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Wound healing speed of corneal epithelial defect for 4 weeks Duration for complete closure of corneal epithelial defect
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	eyedrops
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	non-healed epithelial disorders persistent for 1 week oevr no response for the conventional treatments
Key exclusion criteria	Women who is pregnant or might be pregnant Breast feeding Hypersensitivity to eye drops Pts who are not adequate to enroll
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Naoyuki Middle name Last name Morishige
Organization	Ohshima Eye Hospital
Division name	Division of COrnea and Ocular Surface
Zip code	8120036
Address	11-8 Kami-Gofukumachi, Fukuoka, Fukuoka 8120036, Japan
TEL	092-281-3020
Email	morishig@corneajp.com

Public contact
Name of contact person	1st name Nami Middle name Last name Teramatu
Organization	Ohshima Eye Hospital
Division name	Department of Secretary
Zip code	8120036
Address	11-8 kami-Gofukumachi, Fukuoka, Fukuoka 8120036, Japan
TEL	0922813020
Homepage URL
Email	ohshimah@mocha.ocn.ne.jp

Sponsor
Institute	Ohshima Eye Hospital
Institute
Department

Funding Source
Organization	Ohshima Eye Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board, Ohshima Eye Hospital
Address	11-8 Kami-Gofukumachi
Tel	092-281-3020
Email	morishig@corneajp.com

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 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 12 Month 15 Day
Date of IRB	2016 Year 12 Month 16 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 12 Month 16 Day
Last modified on	2020 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029102