UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028308 |
|---|---|
| Receipt number | R000032390 |
| Scientific Title | The efficacy of contribution by nurse on dry eye patient education |
| Date of disclosure of the study information | 2017/07/20 |
| Last modified on | 2020/06/19 11:49:58 |
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Basic information
Public title
The efficacy of contribution by nurse on dry eye patient education
Acronym
Contribution by nurse on patient education
Scientific Title
The efficacy of contribution by nurse on dry eye patient education
Scientific Title:Acronym
Contribution by nurse on patient education
Region
| Japan |
Condition
Condition
Meibomian gland dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the additional instruction by nurses contribute to the treatment result or not
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective symptoms
Lid margin, tearfilm break up time, tear fluid volume
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
additional instruction in patients education
Interventions/Control_2
warming around eyelids
Twice a day, for one month
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) MGD patients who visit Ohshima Eye Hospital from the approval by IRB through March 2021
2) agreed to be enrolled into this clinical study after explanation of this clinical study
Key exclusion criteria
1) patients who cannot understand the meaning of this clinical study
2) patients who is determined not to be adequate to join this clinical study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Morishige |
Organization
Ohshima Eye Hospital
Division name
Ophthalmology
Zip code
8120036
Address
11-8 Kamigofukumachi, Hakataku, Fukuoka
TEL
092-281-3020
morishig@corneajp.com
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Morishige |
Organization
Ohshima Eye Hospital
Division name
Ophthalmology
Zip code
8120036
Address
11-8 Kamigofukumachi, Hakata-ku, Fukuoka
TEL
092-281-3020
Homepage URL
morishig@corneajp.com
Sponsor or person
Institute
Ohshima Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
Ohshima Eye Hospital
Organization
Division
Category of Funding Organization
Other
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
0922813020
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 | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | 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
| 2017 | Year | 07 | Month | 20 | 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=R000032390
