UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027367 |
|---|---|
| Receipt number | R000031357 |
| Scientific Title | Fact-finding Survey on Allergic Diseases of the Eye |
| Date of disclosure of the study information | 2017/05/18 |
| Last modified on | 2024/02/15 13:15:28 |
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Basic information
Public title
Fact-finding Survey on Allergic Diseases of the Eye
Acronym
Survey on Allergic Diseases of the Eye
Scientific Title
Fact-finding Survey on Allergic Diseases of the Eye
Scientific Title:Acronym
Survey on Allergic Diseases of the Eye
Region
| Japan |
Condition
Condition
Allergic conjunctival disease (ACD)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Survey pathological condition, clinical entity, treatment of allergic conjunctival disease patients at ophthalmology in Japan.
Antigen test will be done for patients want to determine antigen.
Acquire patient background data on allergic conjunctival disease and expand it as evidence of epidemiology at the time of revision of the clinical practice guideline in the future and use it for the prevention and treatment of diseases.
Basic objectives2
Others
Basic objectives -Others
Patient background, clinical entity, pathological condition, treatment of allergic conjunctival disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of ACD in all patients
Current status of clinical practice and treatment
Background information of ACD patients
Change of symptoms score and observations score between first day and re-examination
Steroids combined use rate
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) Hospitalization or Outpatient : Outpatient (both first visit and re-examination possible)
2) Need anti-allergic treatment
3) Capable To answer JACQLQ Questionnaire (Japanese Allergic Conjunctival Disease Quality-of-Life Questionnaire)
Key exclusion criteria
Not applicable
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Okamoto |
Organization
Japanese Ocular Allergology Society
Division name
-
Zip code
169-0075
Address
2-4-7, Takadanobaba, Shinjuku-ku, Tokyo 169-0075, Japan
TEL
03-5287-3801
joas_sec@staffroom.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Okamoto |
Organization
Japanese Ocular Allergology Society
Division name
-
Zip code
169-0075
Address
2-4-7, Takadanobaba, Shinjuku-ku, Tokyo 169-0075, Japan
TEL
03-5287-3801
Homepage URL
joas_sec@staffroom.jp
Sponsor or person
Institute
Japanese Ocular Allergology Society
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Keishokai Ryogoku Ophthalmology Clinic Ethics Review Committee
Address
4-33-12 Ryogoku, Sumida-ku, Tokyo
Tel
03-5600-6886
chisato-higashi@j-smo.com
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
| 2017 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
http://journal.nichigan.or.jp/Disp?style=abst&vol=126&year=2022&mag=0&number=7&start=625
Number of participants that the trial has enrolled
785
Results
The total number of patients seen in the four periods was 18,467, of which 4.3% (785) had allergic conjunctival disease. The percentages of patients with allergic conjunctival disease by disease type (with overlap) were: seasonal allergic conjunctivitis 62.0% (487), perennial allergic conjunctivitis 40.5% (318), atopic keratoconjunctivitis with proliferative lesions 2.8% (22), no proliferative lesions 0.5% (4), Vernal Keratoconjunctivitis 1.8 % (14), and giant papillary conjunctivitis 1.9% (15).
Results date posted
| 2024 | Year | 02 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Refer to paper
Participant flow
Refer to paper
Adverse events
No report
Outcome measures
Proportion of patients with allergic conjunctival disease, pathological conditions/types and their proportions, actual conditions of diagnosis and drug treatment, background of study subjects (gender, age, place of residence, complications, causative antigen, contact lens wearing status, history of eye surgery, etc.)
Change in subjective symptoms (itching, foreign body sensation, hyperemia, lachrymal discharge, ocular grease) score from start date to reexamination, change in other findings score from start date to reexamination, rate of concomitant steroid eye drops
Plan to share IPD
The dataset is not publicly available.
IPD sharing Plan description
The dataset is not publicly available.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate allergic conjunctival disease diagnosis and treatment
Management information
Registered date
| 2017 | Year | 05 | Month | 17 | Day |
Last modified on
| 2024 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031357
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