UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015797 |
|---|---|
| Receipt number | R000018384 |
| Scientific Title | evaluation of epinastine hydrochloride ophthalmic solution in allergic conjunctivitis by conjunctival white birch pollen allergen challenge - double masked, comparison study- |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2015/08/25 08:23:08 |
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Basic information
Public title
evaluation of epinastine hydrochloride ophthalmic solution in allergic conjunctivitis by conjunctival white birch pollen allergen challenge - double masked, comparison study-
Acronym
evaluation of epinastine hydrochloride ophthalmic solution in allergic conjunctivitis by conjunctival white birch pollen allergen challenge - double masked, comparison study-
Scientific Title
evaluation of epinastine hydrochloride ophthalmic solution in allergic conjunctivitis by conjunctival white birch pollen allergen challenge - double masked, comparison study-
Scientific Title:Acronym
evaluation of epinastine hydrochloride ophthalmic solution in allergic conjunctivitis by conjunctival white birch pollen allergen challenge - double masked, comparison study-
Region
| Japan |
Condition
Condition
allergic conjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of epinastine hydrochloride ophthalmic solution in asymptomatic allergic conjunctivitis patients using conjunctival white birch pollen antigen challenge (CAC).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
itching score at 4 hours after drop instillation of action
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
At visit4 and 5, conjunctival challenge is performed with white birch pollen antigen after drop instillation of epinastine hydrochloride ophthalmic solution in asymptomatic allergic conjunctivitis patients.
Interventions/Control_2
At visit4 and 5, conjunctival challenge is performed with white birch pollen antigen after drop instillation of placebo ophthalmic solution in asymptomatic allergic conjunctivitis patients.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Has a positive result from an allergen-specific IgE antibody test of white birch pollen.
Key exclusion criteria
Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
Presence of any abnormality or significant illness that could be expected to interfere with the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Namba |
Organization
Hokkaido University Hospital
Division name
ophthalmology
Zip code
Address
Kita15,Nishi7,Kita-ku,Sapporo
TEL
011-706-5944
knamba@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Namba |
Organization
Hokkaido University Hospital
Division name
ophthalmology
Zip code
Address
Kita15,Nishi7,Kita-ku,Sapporo
TEL
011-706-5944
Homepage URL
knamba@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
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
| 2014 | Year | 12 | 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 | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 21 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 21 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 21 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 30 | Day |
Last modified on
| 2015 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018384
