UMIN-CTR Clinical Trial

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
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
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	Clinical Research Network Fukuoka
Address	3-1-1 Maidashi Higashi-ku Fukuoka, Fukuoka, Japan
Tel	092-643-7171
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031675