UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017641 |
|---|---|
| Receipt number | R000019394 |
| Scientific Title | Efficacy of eyebon AL eye wash trial on allergic conjunctivitis |
| Date of disclosure of the study information | 2015/05/21 |
| Last modified on | 2017/12/28 16:07:58 |
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Basic information
Public title
Efficacy of eyebon AL eye wash trial on allergic conjunctivitis
Acronym
Eye wash efficacy trial by eyebon
Scientific Title
Efficacy of eyebon AL eye wash trial on allergic conjunctivitis
Scientific Title:Acronym
Eye wash efficacy trial by eyebon
Region
| Japan |
Condition
Condition
allergic conjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of eyebon AL eye wash trial on allergic conjunctivitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1: Change in scores of subjective symptoms (JACQLQ)
2: Changes in scores of objective symptoms (JACQLQ)
Key secondary outcomes
Analysis of test liquid
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
eyebon AL
Interventions/Control_2
saline solution
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
| 13 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients presenting with conjunctiva at hyperemia and inflamation(conduct in patients with grater than grade 2 hyperemia)
Key exclusion criteria
1.Patients have a symptom of eye pain.
2.Patients have had ocular surgical intervention within a year.
3.Patients take steroid drug for treatment of allergic disease.
4.Patients have an allergy to test liquid.
5.Patient who the investigator considers ineligible for enrolment.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Fujishima |
Organization
Tsurumi University School of Dental Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, Japan.
TEL
045-580-8599
fujishima117@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Arimoto |
Organization
KOBAYASHI Pharmaceutical Co.,Ltd
Division name
R&D Healthcare Division
Zip code
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka567-0057, JAPAN
TEL
072-640-0125
Homepage URL
m.arimoto@kobayashi.co.jp
Sponsor or person
Institute
KOBAYASHI Pharmaceutical Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fujishima eye clinic
Ryogoku eye clinic
Department of Ophthalmology, Fukuoka university School of Medicine
Department of Earth System Science, Faculty of Science, Fukuoka University
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
鶴見大学歯学部附属病院眼科（神奈川県）、両国眼科クリニック（東京都）、藤島眼科医院（新潟県）、福岡大学医学部眼科（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Japan Cornea Conference 2017
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
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | 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 | 05 | Month | 21 | Day |
Last modified on
| 2017 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019394
