UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025299
Receipt No. 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 2016/12/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Naoyuki Morishige
Organization Ohshima Eye Hospital
Division name Division of COrnea and Ocular Surface
Zip code
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
Middle name
Last name Nami Teramatu
Organization Ohshima Eye Hospital
Division name Department of Secretary
Zip code
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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2016 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
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
2016 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.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


Contact us.