UMIN-CTR Clinical Trial

Basic information
Public title	Clinical findings and analysis of treatment in patients with allergic disease
Acronym	Clinical findings of allergic disease
Scientific Title	Clinical findings and analysis in patients with allergic disease
Scientific Title:Acronym	Clinical findings and analysis in patients with allergic disease
Region	Japan

Condition
Condition	Allergic Conjunctival disease and allergy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	At Yamana Eye clinic, many patients complain of itching and redness of eyes and develop allergic conjunctival disease. For the treatment of allergic conjunctival diseases, sublingual allergen immunotherapy is used as well as eye drops such as antihistamines, steroids, and immunosuppressants, oral administration and ointment. We have routinely examined suspected allergic conjunctivitis using the inspection methods of total tear IgE test, specific serum IgE, total serum IgE test based on the current standard guidelines for the clinical management of allergic conjunctival diseases (2010, 2nd edition) of the Japanese Ophthalmology Society. We investigate the prevalence of allergic conjunctival disease by disease, gender, age, the treatment course for severe cases such as vernal keratoconjunctivitis, effect and patient satisfaction of sublingual immunotherapy on specific allergens, and also the relationship between pollen dispersal and microparticulate matter (PM2.5), which has become a problem in recent years, and the relationship between total tear IgE test, total serum IgE test and specific serum IgE test. The purpose of this study is to accurately and in detail grasp the pathological condition of allergic conjunctival disease, and to utilize it for treatment.
Basic objectives2	Others
Basic objectives -Others	Prevalence, pathology, etiology, and consideration of outcomes through methods, processes, and courses of treatment, etc.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To understand the current prevalence and condition of allergic conjunctival diseases by age, as well as the effects of therapeutic agents, and to clarify the classification, characteristics, and condition based on symptoms and findings, and test results. Also, based on the results, select the most appropriate therapeutic drug for each patient so that the effect can be judged.
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. the patients who are visiting Yamana Eye Clinic 2. the patients complaining of allergic symtoms such as eye itching, discomfort, redness, swelling, eye mucus, nasal discharge, sneezing and stuffy nose, who wish for detailed examination and treatment by themselves
Key exclusion criteria	the patients who have not undergone total tear IgE test, specific serum IgE test, total serum IgE test, etc.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Yasuo Middle name Last name Yamana
Organization	Yamana Eye Clinic
Division name	Ophthalmology Allergology
Zip code	809-0022
Address	13-5 Nabeyama-machi Nakama Fukuoka, Japan
TEL	093-246-2345
Email	yamanaganka@yamana.or.jp

Public contact
Name of contact person	1st name Yasuo Middle name Last name Yamana
Organization	Yamana Eye Clinic
Division name	Ophthalmology Allergology
Zip code	809-0022
Address	13-5 Nabeyama-machi Nakama Fukuoka, Japan
TEL	093-246-2345
Homepage URL
Email	yamanaganka@yamana.or.jp

Sponsor
Institute	Yamana Eye Clinic
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the Ethics Committee of Japan Clinical Diabetes Association
Address	1-13-6 Nakasone Kokuraminami-ku Kitakyushu Fukuoka, Japan
Tel	093-473-0300
Email	kayfujii@a1.rimnet.ne.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	2020 Year 10 Month 02 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	Enrolling by invitation
Date of protocol fixation	2019 Year 09 Month 02 Day
Date of IRB	2019 Year 12 Month 09 Day
Anticipated trial start date	2020 Year 02 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Observation items; 1. Patients background information: age, sex, medical history, prescription drugs, symptoms 2. clinical examination: findings of eyelid, palpebral conjunctiva, ocular conjunctiva, corneal by slit lamp microscope Total tear IgE test (Allerwatch tear IgE), specific serum IgE test(View allergy 39), total serum IgE test, palpebral conjunctiva, microscopic examination by Diff-Quik stain 3. diagnostic imaging; slit lamp micrograph, photograph of fundus 4. Questionnaire: Japanese Allergic Conjunctivitis standard QOL questionnaire ver.1

Management information
Registered date	2020 Year 10 Month 02 Day
Last modified on	2020 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047530