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
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
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
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
