UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022620 |
|---|---|
| Receipt number | R000026074 |
| Scientific Title | the effect of Prokera slim in dry eye syndrome |
| Date of disclosure of the study information | 2016/06/07 |
| Last modified on | 2016/06/06 10:18:05 |
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Basic information
Public title
the effect of Prokera slim in dry eye syndrome
Acronym
the effect of Prokera slim in dry eye syndrome
Scientific Title
the effect of Prokera slim in dry eye syndrome
Scientific Title:Acronym
the effect of Prokera slim in dry eye syndrome
Region
| Japan |
Condition
Condition
Dry eye syndrome
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the effect of Prokera slim in ocular symptoms and corneal dye staining.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Corneal dye staining score 5 days after treatment with Prokera slim
Key secondary outcomes
Visual acuity and ocular symptoms 5 days after treatment with Prokera slim
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
Treatment by Prokera slim /
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
Dry eye syndrome (DEWS score >=3)
Key exclusion criteria
1. Diseases with potential corneal nerve injury
2. Ocular infection within 2 weeks
3. Ocular surgery within 3 months
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kawakita |
Organization
Keio University School of Medicine
Division name
Dept. of Ophthamology
Zip code
Address
35 Shinanomachi, Shinjuku,Tokyo
TEL
03-3353-1211
kawakita@a2.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kawakita |
Organization
Keio University School of Medicine
Division name
Dept. of Ophthamology
Zip code
Address
35 Shinanomachi, Shinjuku,Tokyo
TEL
03-3353-1211
Homepage URL
kawakita@a2.keio.jp
Sponsor or person
Institute
Minami Aoyama Eye Clinic
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
| 2016 | Year | 06 | Month | 07 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | 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 | 06 | Month | 06 | Day |
Last modified on
| 2016 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026074
