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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051686