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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039592
Receipt No. R000045122
Scientific Title Investigations of ocular side effects of topically applied 0.002% EYBELIS
Date of disclosure of the study information 2020/03/07
Last modified on 2020/02/25

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Basic information
Public title Investigations of ocular side effects of
topically applied 0.002% EYBELIS
Acronym Investigations of ocular side effects of
topically applied 0.002% EYBELIS
Scientific Title Investigations of ocular side effects of
topically applied 0.002% EYBELIS
Scientific Title:Acronym Investigations of ocular side effects of
topically applied 0.002% EYBELIS
Region
Japan

Condition
Condition Glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate onset of ocular inflammation induced by topical 0.002% EYBELIS
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measure the aqueous flare by means of laser-flare metry
Key secondary outcomes Measure the intraocular pressure by means of tonometry

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Primary open angle glaucoma without any other ocular complications
Key exclusion criteria Pathologies associate with ocular inflammation such as diabetes mellitus
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kensaku
Middle name
Last name Miyake
Organization Shohzankai Medical Foundation Miyake Eye Hospital
Division name Director
Zip code 462-0825
Address 3-14-20, Ozone, Kita-ku, Nagoya 462-0825 JAPAN
TEL 052-915-8001
Email miyake@spice.or.jp

Public contact
Name of contact person
1st name Kensaku
Middle name
Last name Miyake
Organization Shohzankai Medical Foundation Miyake Eye Hospital
Division name Director
Zip code 462-0825
Address 3-14-20, Ozone, Kita-ku, Nagoya 462-0825 JAPAN
TEL 052-915-8001
Homepage URL
Email miyake@spice.or.jp

Sponsor
Institute Shohzankai Medical Foundation Miyake Eye Hospital
Institute
Department

Funding Source
Organization Shohzankai Medical Foundation Miyake Eye Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Miyake Eye Hospital Institutional Review Board
Address 3-14-20, Ozone, Kita-ku, Nagoya 462-0825 JAPAN
Tel 052-915-8001
Email miyake@spice.or.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

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 07 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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 15 Day
Date of IRB
2018 Year 10 Month 29 Day
Anticipated trial start date
2018 Year 12 Month 03 Day
Last follow-up date
2020 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The study is carried out not as a meta-analysis but as a kind of observational study, thus the details are already described in the above questions and answers.

Management information
Registered date
2020 Year 02 Month 25 Day
Last modified on
2020 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045122

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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