UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036118
Receipt No. R000041095
Scientific Title Questionnaire survey on use of anti- allergic ophthalmic solutions for patients with seasonal allergic conjunctivitis
Date of disclosure of the study information 2019/03/12
Last modified on 2019/03/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Questionnaire survey on use of anti- allergic ophthalmic solutions for patients with seasonal allergic conjunctivitis
Acronym Questionnaire survey on use of anti- allergic ophthalmic solutions for patients with seasonal allergic conjunctivitis
Scientific Title Questionnaire survey on use of anti- allergic ophthalmic solutions for patients with seasonal allergic conjunctivitis
Scientific Title:Acronym Questionnaire survey on use of anti- allergic ophthalmic solutions for patients with seasonal allergic conjunctivitis
Region
Japan

Condition
Condition seasonal allergic conjunctivitis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Ask a questionnaire for patients with seasonal allergic conjunctivitis.
Basic objectives2 Others
Basic objectives -Others Relationship between drug adherence status and background of Patients
Effect of treatment satisfaction and QOL with ophthalmic solutions adherence status

Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between drug adherence status and background of Patients
Effect of treatment satisfaction and QOL with ophthalmic solutions adherence status

Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects diagnosed with seasonal allergic conjunctivitis by ophthalmologist and used of anti-allergic ophthalmic solutions after the end of 2018.
Subjects with seasonal allergic conjunctivitis such as eye itch after the end of 2018.
Key exclusion criteria Medical staff (including doctor, pharmacist, nurse)
Subjects engaged in pharmaceuticals and medical devices industry
Subjects engaged in pharmaceuticals distributor
Subjects engaged in information provision service , research and advertisement industry
Subjects with severe allergic conjunctivitis (vernal keratoconjunctivitis , atopic keratoconjunctivitis )
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Naruhiro
Middle name
Last name Ishida
Organization Santen Pharmaceutical Co., Ltd.
Division name Japan Medical Affairs, Development Management Department, Japan Business
Zip code 530-8552
Address 4-20, Ofukacho, Kita-ku, Osaka
TEL 06-4802-9603
Email clinical@santen.co.jp

Public contact
Name of contact person
1st name Naomi
Middle name
Last name Otsuka
Organization Santen Pharmaceutical Co., Ltd.
Division name Japan Medical Affairs, Development Management Department, Japan Business
Zip code 530-8552
Address 4-20, Ofukacho, Kita-ku, Osaka
TEL 06-4802-9603
Homepage URL
Email clinical@santen.co.jp

Sponsor
Institute Santen Pharmaceutical Co., Ltd.
Institute
Department

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 TOUKEIKAI Kitamachi Clinic ERB
Address 1, 3, Kichijoji Kita-cho, Musashino-shi, Tokyo
Tel 070-5011-8550
Email shingo-namiki@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
2019 Year 03 Month 12 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 Open public recruiting
Date of protocol fixation
2019 Year 03 Month 01 Day
Date of IRB
2019 Year 03 Month 08 Day
Anticipated trial start date
2019 Year 03 Month 12 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Questionnaire survey on use of anti-allergic ophthalmic solutions for patients with seasonal allergic conjunctivitis

Management information
Registered date
2019 Year 03 Month 07 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041095

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.