UMIN-CTR Clinical Trial

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
Email	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
Email	ophthalmolog1st.acek39@gmail.com

Sponsor
Institute	Keio University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044085