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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044085


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name