UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002709 |
|---|---|
| Receipt number | R000003305 |
| Scientific Title | Clinical efficacy of the PHSRN peptide from fibronectin eye drops for intractable corneal epithelial disorders. |
| Date of disclosure of the study information | 2009/11/04 |
| Last modified on | 2011/11/09 21:01:13 |
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Basic information
Public title
Clinical efficacy of the PHSRN peptide from fibronectin eye drops for intractable corneal epithelial disorders.
Acronym
Clinical efficacy of the PHSRN peptide eye drops for intractable corneal epithelial disorders.
Scientific Title
Clinical efficacy of the PHSRN peptide from fibronectin eye drops for intractable corneal epithelial disorders.
Scientific Title:Acronym
Clinical efficacy of the PHSRN peptide 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 the PHSRN peptide from fibronectin eye drops for intractable corneal epithelial disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AD classification for SPK
Time to complete healing for persistent 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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PHSRN eye drop
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 defects 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 allegy for this agents
4.Were judged an inadequate subject to enrollment by a medical doctor
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruo Nishida |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-1-1 Minami-Kogushi, Ube city, Yamaguchi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 11 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 04 | Day |
Last modified on
| 2011 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003305
