UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034516 |
|---|---|
| Receipt number | R000039250 |
| Scientific Title | The effect of a commercial eye wash solution on the ocular surface mucin layer |
| Date of disclosure of the study information | 2018/10/25 |
| Last modified on | 2018/10/16 12:53:56 |
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Basic information
Public title
The effect of a commercial eye wash solution on the ocular surface mucin layer
Acronym
The effect of a commercial eye wash solution on the ocular surface mucin layer
Scientific Title
The effect of a commercial eye wash solution on the ocular surface mucin layer
Scientific Title:Acronym
The effect of a commercial eye wash solution on the ocular surface mucin layer
Region
| Japan |
Condition
Condition
normal subjects
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the corneal epithelium and ocular surface mucins after one month use of a commercial preservative free eye wash solution
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mRNA expressions of MUC5AC and MUC16
Key secondary outcomes
1.Dry Eye-related Quality of life Score (DEQS)
2.Tear film break-up time(BUT)
3.Corneal epithelial damage
4.Microflora analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
A commercial eye wash solution(Eyebon w)was used for monocular eye wash.
Interventions/Control_2
no treatment
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients not using contact lenses.
2.Patients who had ocular surgery before the last six months.
3.patients who understands the contents of the consent document and is able to consent in the document of the person.
Key exclusion criteria
1.Patients who have any disease.
conjunctival injection
dry eye symptoms
corneal epithelial damage
2.Patients who take current medications during the past one month .
3.Patients using contact lenses.
4.Patients judged by other research managers or researchers as inappropriate to implement this research safely.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Fujishima |
Organization
Tsurumi University School of Dental Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, Japan.
TEL
045-580-8599
fujishima117@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Fujishima |
Organization
Tsurumi University School of Dental Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, Japan.
TEL
045-580-8599
Homepage URL
fujishima117@gmail.com
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
Funding Source
Organization
Kobayashi International Scholarship Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2018 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The 72nd annual congress of japan clinical opthhalmology(2018)
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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 15 | 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
| 2018 | Year | 10 | Month | 16 | Day |
Last modified on
| 2018 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039250
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
