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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002709
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003305

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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