UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of IOP reduction and safety of Eybelis ophthalmic solution 0.002%
Acronym	Efficacy of IOP reduction and safety of Eybelis ophthalmic solution 0.002%
Scientific Title	Efficacy of IOP reduction and safety of Eybelis ophthalmic solution 0.002%
Scientific Title:Acronym	Efficacy of IOP reduction and safety of Eybelis ophthalmic solution 0.002%
Region	Japan

Condition
Condition	glaucoma or ocular hypertension
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy of IOP reduction and safety of Ebelis ophtamlic solution 0.002% for untreated patients with glaucoma or ocular hypertension who needs eye treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	IOP reduction Adverse event
Key secondary outcomes	Feeling of use

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Topical ophthtalmic therapy with Eberis ophthalmic solution 0.002%
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with unilateral or bilateral primary open angle glaucoma or ocular hypertension
Key exclusion criteria	Patients with aphakic eye or implanted IOL in the eye (history of cataract surgery), Patients with cataract surgery scheduled (within the last 6 months) Patients with some corneal abnormality or other diseases which may interfere with accurate IOP measurement using Goldmann applanation tonometer Patients with a history of corneal refractive surgery Patients with active extraocular disease, inflammation or infection in the eye(s) or eyelid(s) Patients with allergy to the ingredients used in the present study Pregnant, lactating women or women who may be pregnant, and women who wish to be pregnant or can not conduct appropriate contraception during the study period
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Inoue
Organization	Inouye Eye Hospital
Division name	Medical office
Zip code	1010062
Address	4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL	03-3295-0911
Email	study@inouye-eye.or.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Inoue
Organization	Inouye Eye Hospital
Division name	Medical office
Zip code	1010062
Address	4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL	03-3295-0911
Homepage URL
Email	study@inouye-eye.or.jp

Sponsor
Institute	Inouye Eye Hospital
Institute
Department

Funding Source
Organization	None
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	Inouye Eye Hospital ethics committee
Address	4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
Tel	03-3295-0911
Email	study@inouye-eye.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	2018 Year 12 Month 13 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	2018 Year 12 Month 05 Day
Date of IRB	2018 Year 12 Month 03 Day
Anticipated trial start date	2018 Year 12 Month 10 Day
Last follow-up date	2023 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 13 Day
Last modified on	2021 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040112