UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039592
Receipt number 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 14:40:45

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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 or person

Institute

Shohzankai Medical Foundation Miyake Eye Hospital

Institute

Department

Personal name



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

Value
https://center6.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