UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045629 |
|---|---|
| Receipt number | R000051686 |
| Scientific Title | Relationship between clinical disease severity and stress in allergic conjunctival diseases |
| Date of disclosure of the study information | 2021/10/10 |
| Last modified on | 2021/10/01 15:19:39 |
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Basic information
Public title
Relationship between severity of allergic conjunctival diseases and stress
Acronym
Severity of allergic conjunctival diseases and stress
Scientific Title
Relationship between clinical disease severity and stress in allergic conjunctival diseases
Scientific Title:Acronym
Relationship between severity of allergic conjunctival disease and stress
Region
| Japan |
Condition
Condition
Allergic conjunctival diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the impact of stress in patients with severe allergic conjunctival disease.
Basic objectives2
Others
Basic objectives -Others
Correlation between psychological tests and subjective symptoms and objective findings scores
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigation of subjective symptoms and objective Findings Scores Associated with assessment results of psychological tests.
Key secondary outcomes
1) Verification of correlation among psychological tests, subjective symptom scores, and objective findings scores.
2) An exploratory study of psychological tests, subjective symptom scores, and objective findings scores as useful biomarkers of allergic conjunctival diseases.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 7 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Allergic conjunctival diseases patients with a confirmed or semi-confirmed diagnosis according to the Japanese guidelines for the allergic conjunctival diseases.
(2) The gender, clinical forms, and the contents of treatment of the patients are irrelevant.
(3) The age of the patient must be at least 7 years old at the time of obtaining consent, and there is no upper age limit.
(4) Patients who have received sufficient explanation for participation in this study and have given written consent of their own free will with full understanding.
Key exclusion criteria
(1) Patients with anterior ocular diseases (including ocular infections) other than allergic conjunctival diseases.
(2) Patients who did not give consent to participate in this study.
(3) Patients who have difficulty filling out the survey form.
(4) Persons whom the principal investigator judges to be inappropriate as research subjects.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Yamagami |
Organization
Nihon University School of Medicine
Division name
Division of Ophthalmology, Department of Visual Sciences
Zip code
1738610
Address
30-1 Ooyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
TEL
0339728111
yamagami.satoru@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Shoji |
Organization
Nihon University School of Medicine
Division name
Division of Ophthalmology, Department of Visual Sciences
Zip code
1738610
Address
30-1 Ooyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
TEL
0339728111
Homepage URL
Shoji.jun@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
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
Tokaigakuen University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Medicine Itabashi Hospital Clinical Research Ethics Review Board
Address
30-1 Ooyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
Tel
0339728111
med.itabashi.chiken@nihon-u.ac.jp
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
| 2021 | Year | 10 | Month | 10 | 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
| 2021 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The survey table is
1. JACQLQ survey table (supervised by the Japanese Society of Allergology)
2. FISA survey table (Nihon University Ophthalmology original)
3. POASM survey table (Nihon University Ophthalmology original)
4. Japanese version of overt anxiety test for children CMAS (manufactured by Sankyobo)
5. Japanese version STAI (manufactured by Sankyobo)
Management information
Registered date
| 2021 | Year | 10 | Month | 01 | Day |
Last modified on
| 2021 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051686
