UMIN-CTR Clinical Trial

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
Email	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
Email	Shoji.jun@nihon-u.ac.jp

Sponsor
Institute	Nihon University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051686