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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035193
Receipt No. R000040066
Scientific Title Efficacy of IOP reduction and safety of Eybelis ophthalmic solution 0.002% switched from Prostaglandin analog.
Date of disclosure of the study information 2018/12/10
Last modified on 2018/12/10

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Basic information
Public title Efficacy of IOP reduction and safety of Eybelis ophthalmic solution 0.002% switched from Prostaglandin analog.
Acronym Efficacy of IOP reduction and safety of Eybelis ophthalmic solution 0.002% switched from Prostaglandin analog.
Scientific Title Efficacy of IOP reduction and safety of Eybelis ophthalmic solution 0.002% switched from Prostaglandin analog.
Scientific Title:Acronym Efficacy of IOP reduction and safety of Eybelis ophthalmic solution 0.002% switched from Prostaglandin analog.
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 Eybelis ophthalmic solution 0.002% switched from Prostaglandin analog in patients with glaucoma or ocular hypertension.
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 Switching from Prostaglandin analog to Eybelis 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
Patients with some deepening of upper eyelid sulcus after topical use of prostaglandin analogs
good adherence before the study initiation
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
Middle name
Last name Kenji Inoue
Organization Inouye Eye Hospital
Division name Medical office
Zip code
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
Middle name
Last name Kenji Inoue
Organization Inouye Eye Hospital
Division name Medical office
Zip code
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
Address
Tel
Email

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 10 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
Anticipated trial start date
2018 Year 12 Month 07 Day
Last follow-up date
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 10 Day
Last modified on
2018 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040066

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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