UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012954
Receipt No. R000015146
Scientific Title Evaluation of efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctival diseases in the senior persons.
Date of disclosure of the study information 2014/01/31
Last modified on 2020/02/27

* 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 Evaluation of efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctival diseases in the senior persons.
Acronym Evaluation of efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctival diseases in the senior persons.
Scientific Title Evaluation of efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctival diseases in the senior persons.
Scientific Title:Acronym Evaluation of efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctival diseases in the senior persons.
Region
Japan

Condition
Condition Allergic conjunctivitis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of epinastine hydrochloride ophthalmic solution, anti-allergic ophthalmic solution, for allergic conjunctival diseases in the senior persons.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes improvement of subjective symptoms
improvement of objective finding
Key secondary outcomes quantitative evaluation of hyperemia

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Epinastine hydrochloride ophthalmic solution
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria a) patients with allergic conjunctival diseases
1)Patients who provided written informed consent for participating in this study.
2)Only the data gathered from MAST-33 positive patients are examined.
Key exclusion criteria Patients who cannot discontinue the drugs that may have an influence on evaluation of drug efficacy, such as steroids, immunosuppression agent.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tamaki Sumi
Organization Kochi Medical School
Division name Department of Ophthalmology
Zip code
Address Kohasu, Oko-cho, Nankoku-Kochi
TEL 088-880-2391
Email sumitama@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tamaki Sumi
Organization Kochi Medical School
Division name Department of Ophthalmology
Zip code
Address Kohasu, Oko-cho, Nankoku-Kochi
TEL 088-880-2391
Homepage URL
Email sumitama@kochi-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Kochi Medical School
Institute
Department

Funding Source
Organization Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 01 Month 31 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000015146
Publication of results Unpublished

Result
URL related to results and publications 0
Number of participants that the trial has enrolled 0
Results Number of participants that the trial has enrolled is 0. So not result.
Results date posted
2020 Year 02 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics none
Participant flow none
Adverse events none
Outcome measures none
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2013 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 01 Day
Last follow-up date
2014 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 24 Day
Last modified on
2020 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015146

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.