UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041978 |
|---|---|
| Receipt number | R000047530 |
| Scientific Title | Clinical findings and analysis in patients with allergic disease |
| Date of disclosure of the study information | 2020/10/02 |
| Last modified on | 2020/10/02 09:09:07 |
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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
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
yamanaganka@yamana.or.jp
Sponsor or person
Institute
Yamana Eye Clinic
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047530
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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