UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016313 |
|---|---|
| Receipt number | R000018935 |
| Scientific Title | Efficacy of epinastine hydrochloride ophthalmic solution in patients with allergic conjunctivitis |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2016/02/25 13:55:44 |
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Basic information
Public title
Efficacy of epinastine hydrochloride ophthalmic solution in patients with allergic conjunctivitis
Acronym
Efficacy of epinastine hydrochloride ophthalmic solution in patients with allergic conjunctivitis
Scientific Title
Efficacy of epinastine hydrochloride ophthalmic solution in patients with allergic conjunctivitis
Scientific Title:Acronym
Efficacy of epinastine hydrochloride ophthalmic solution in patients with allergic conjunctivitis
Region
| Japan |
Condition
Condition
Allergic conjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of epinastine hydrochloride ophthalmic solution in patients with allergic conjunctivitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in scores of subjective symptoms
Change in scores of objective findings
Key secondary outcomes
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, apply 1 drop a time, 4 times daily, for 4 weeks
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with moderate (*)and more moderate eye itching at the time of obtaining informed consent
*Moderate: score 2 or more in five rated below
0: No symptoms, 1: mild, 2: slightly heavy,
3: heavy, 4: Very heavy
2)Patients scheduled for wearing the same product of contact lenses if they are wearing contact lenses during the test period.
Key exclusion criteria
1)Females who are or may be pregnant, or lactating
2)Patients with a history of hypersensitivity to study drug or test material
3)Patient who the investigator considers ineligible for enrolment.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Watanabe |
Organization
Watanabe eye clinic
Division name
Watanabe eye clinic
Zip code
Address
5-5270 Osaka ekimae Diamond Chikagai Umeda 1cho-me Kita-ku Osaka
TEL
06-6456-4455
watanabe@jpncl.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Watanabe |
Organization
Watanabe eye clinic
Division name
Watanabe eye clinic
Zip code
Address
5-5270 Osaka ekimae Diamond Chikagai Umeda 1cho-me Kita-ku Osaka
TEL
06-6456-4455
Homepage URL
watanabe@jpncl.com
Sponsor or person
Institute
Watanabe eye clinic
Institute
Department
Personal name
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
Address
Tel
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
| 2015 | Year | 02 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 23 | Day |
Last modified on
| 2016 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018935
| Research Plan | |
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| 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 |
