UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025299
Receipt number R000029102
Scientific Title The efficacy of fibronectin eye drops on non-healed corneal epithelial disorders
Date of disclosure of the study information 2017/01/01
Last modified on 2020/06/19 11:51:24

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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 or person

Institute

Ohshima Eye Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029102


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name