UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027651 |
|---|---|
| Receipt number | R000031675 |
| Scientific Title | The study of total tear and specific serum IgE in patients with allergic conjunctivitis |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2019/12/09 11:30:57 |
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Basic information
Public title
The study of total tear and specific serum IgE in patients with allergic conjunctivitis
Acronym
The study of total tear and specific serum IgE
Scientific Title
The study of total tear and specific serum IgE in patients with allergic conjunctivitis
Scientific Title:Acronym
The study of total tear and specific serum IgE
Region
| Japan |
Condition
Condition
allergic conjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have routinely examined suspected allergic conjunctivitis using the inspection methods of total tear IgE test and specific serum IgE test based on the current standard guildlines for the clinical management of allergic conjunctival diseases (2010, 2nd edition) of the Japanese Ophthalmology Society.
We have found notable divergence between findings in our cases and those findings suggested by the guidelines. Therefore, like the local allergic rhinitis described in 2016 in the Otolaryngology Guideline, this study aims to ascertain whether there is a certain proportion of local allergic conjunctivitis and non-IgE type local allergic conjunctivitis.
Basic objectives2
Others
Basic objectives -Others
Prevalence of Local Allergic Conjunctivitis
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of local allergic conjunctivitis and non-IgE type local allergic conjunctivitis
The percentage of cases diagnosed as local allergic conjunctivitis and non-IgE type local allergic conjunctivitis in the group to be analyzed
Key secondary outcomes
1.The distribution of the result of total tear IgE test and specific serum IgE test: the percentage of positive and negative cases of specific serum IgE test in positive and negative cases of total tear IgE test
2.The ratio of eosinophils in conjunctival scraping specimens: the percentage of positive cases of eosinophils in conjunctival craping specimens in the group to be analyzed
3.Relation between the precalence of local allergic conjunctivitis and non-IgE type local allergic conjunctivitis and background factor
4.Relation between each prevalence and the following background factor: age and sex
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 visited in Yamana Eye Clinic on Dec. 1, 2013 to March 31, 2017
2. the patients complaining of allergic symptoms such as eye itching, discomfort, congestion, swelling and stuffy nose
Key exclusion criteria
The patients without total tear IgE test and specific serum IgE test
Target sample size
148
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Yamana |
Organization
Yamana Eye Clinic
Division name
Ophthalmology
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
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
Clinical Research Network Fukuoka
Address
3-1-1 Maidashi Higashi-ku Fukuoka, Fukuoka, Japan
Tel
092-643-7171
mail@crnfukuoka.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
| 2017 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
148
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
Main results already published
Date of protocol fixation
| 2017 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 18 | 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 (immunoCAP rapid and View allergy 39), palpebral conjunctiva, microscopic examination by Eosinostein staining
3. diagnostic imaging; slit lamp micrograph, photograph of fundus
4. Questionnaire: Japanese Allergic Conjunctivitis standard QOL questionnaire ver.1
Factors to consider
Allergic testing case: among the subjects to be studies, the cases in which total tear IgE test and specific serum IgE test were performed.
Local allergic conjunctivitis cases: the cases where allergens could not be identified by specific serum IgE test, despite positive in total tear IgE test.
Non-IgE type local allergic conjunctivitis: negative in total tear IgE test, and allergen could not be identified by specific serum IgE test, but the cases with eosinophils confirmed by palpebral conjunctiva rubbing.
Management information
Registered date
| 2017 | Year | 06 | Month | 06 | Day |
Last modified on
| 2019 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031675
