UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038675 |
|---|---|
| Receipt number | R000044085 |
| Scientific Title | Observation of changes in ocular findings before and after the use of the IL-4 and 13 antibody preparation dupilumab |
| Date of disclosure of the study information | 2019/11/26 |
| Last modified on | 2021/04/16 13:38:56 |
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Basic information
Public title
Observation of changes in ocular findings before and after the use of the IL-4 and 13 antibody preparation dupilumab
Acronym
dupilumab
Scientific Title
Observation of changes in ocular findings before and after the use of the IL-4 and 13 antibody preparation dupilumab
Scientific Title:Acronym
dupilumab
Region
| Japan |
Condition
Condition
Atopic dermatitis, bronchial asthma, sinusitis, and ocular disorders
Classification by specialty
| Pneumology | Ophthalmology | Dermatology |
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the pathogenesis of allergic conjunctivitis, which has been reported to be a type of adverse reaction associated with dupilumab, as well as to investigate potential adverse events in ophthalmology.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity, intraocular pressure, refractive value, corneal curvature radius, axial length, Schirmer test, fluorescein score, Rose Bengal or Lissaing Lean score, tear film breakup time, subjective symptom OSDI, optic nerve flicker, imaging findings, blood sampling test, tear fluid, cytology, etc.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 12 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients using dupilumab who have accepted ophthalmologic examinations and this study
Key exclusion criteria
Patients who have refused to provide clinical information to this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Uchino |
Organization
Department of Ophthalmology, Keio University School of Medicine
Division name
Ophthalmology
Zip code
1600016
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
03-5363-3821
hmpgx653@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Eisuke |
| Middle name | |
| Last name | Shimizu |
Organization
Department of Ophthalmology, Keio University School of Medicine
Division name
Ophthalmology
Zip code
1600016
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
03-5363-3821
Homepage URL
ophthalmolog1st.acek39@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tsurumi University School of Dental Medicine
Name of secondary funder(s)
Tsurumi University School of Dental Medicine
IRB Contact (For public release)
Organization
Department of Ophthalmology, Keio University School of Medicine
Address
35 Shinanomachi Shinjuku-ku Tokyo
Tel
03-5363-3821
ophthalmolog1st.acek39@keio.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
慶應義塾大学病院（東京都）、鶴見大学歯学部附属病院（神奈川県）、両国眼科（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 26 | 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 | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study is designed to evaluate ocular adverse events associated with dupilumab
Management information
Registered date
| 2019 | Year | 11 | Month | 25 | Day |
Last modified on
| 2021 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044085
