UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012954 |
|---|---|
| Receipt number | 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 | 2022/02/13 10:08:16 |
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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 | Tamaki |
| Middle name | |
| Last name | Sumi |
Organization
Kochi Medical School
Division name
Department of Ophthalmology
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku-Kochi
TEL
088-880-2391
sumitama@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Tamaki |
| Middle name | |
| Last name | Sumi |
Organization
Kochi Medical School
Division name
Department of Ophthalmology
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku-Kochi
TEL
088-880-2391
Homepage URL
sumitama@kochi-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kochi Medical School
Institute
Department
Personal name
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
Ethucal Review Board
Address
Kohasu, Oko-cho, Nankoku-Kochi
Tel
088-880-2719
im62@kochi-u.ac.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
| 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
| 2022 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015146
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
