UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035627 |
|---|---|
| Receipt number | R000040586 |
| Scientific Title | Efficacy of eye wash trial with Wellwasheye |
| Date of disclosure of the study information | 2019/01/22 |
| Last modified on | 2019/01/22 19:04:04 |
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Basic information
Public title
Efficacy of eye wash trial with Wellwasheye
Acronym
Eye wash efficacy by Wellwasheye
Scientific Title
Efficacy of eye wash trial with Wellwasheye
Scientific Title:Acronym
Eye wash efficacy by Wellwasheye
Region
| Japan |
Condition
Condition
Allergic conjunctivitis disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of allergic conjunctiva disease by Wellwosseye
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Change in subjective symptom score (JACQLQ)
2.Changes in objective symptom score (JACQLQ)
3.Changes in conjunctival injection score
Key secondary outcomes
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
Wellwasheye
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with allergic conjunctivitis disease
Key exclusion criteria
1 Patients with a past history of ocular surgery.
2. Patient who can not use eye drops.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Mimura |
Organization
Teikyo University
Division name
School of Medicine, Department of Ophthalmology
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL
03-3964-1211
mimurat@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Mimura |
Organization
Teikyo University
Division name
School of Medicine, Department of Ophthalmology
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL
03-3964-1211
Homepage URL
mimurat@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Ophthalmology Tsurumi University Dental Hospital, Ryogoku Eye Clinic, Fujishima Eye Clinic
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
| 2019 | Year | 01 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 22 | 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
| 2019 | Year | 01 | Month | 22 | Day |
Last modified on
| 2019 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040586
