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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034978
Receipt No. R000039887
Scientific Title Time course of conjuctival hyperemia induced by eybelis ophthalmic solution 0.002%
Date of disclosure of the study information 2018/11/23
Last modified on 2018/11/22

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Basic information
Public title Time course of conjuctival hyperemia induced by eybelis ophthalmic solution 0.002%
Acronym Time course of conjuctival hyperemia induced by eybelis ophthalmic solution 0.002%
Scientific Title Time course of conjuctival hyperemia induced by eybelis ophthalmic solution 0.002%
Scientific Title:Acronym Time course of conjuctival hyperemia induced by eybelis ophthalmic solution 0.002%
Region
Japan

Condition
Condition Healthy subjects and patients with glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the time course of conjuctival hyperemia induced by eybelis ophthalmic solution 0.002%.
To evaluate the ocular side effects induced by eybelis ophthalmic solution.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time course of conjuctival hyperemia and the ocular side effects indued by eybelis ophthalmic solution.
Key secondary outcomes Intraocular pressure

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Healthy subjects and patients with glaucoma
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Healthy subjects with no ocular disease and no ocular surgery.

Primary open angle glaucoma patients without lens extraction.
Key exclusion criteria Except for participants with inclusion criteria and female with pregnant.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Nakakura
Organization Saneikai Tsukazaki Hosipital
Division name Ophthalmology
Zip code
Address Himeji City Aboshi Waku 68-1
TEL 0792728550
Email shunsukenakakura@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Nakakura
Organization Tsukazaki Hospital
Division name Ophthalmology
Zip code
Address Himeji City Aboshi Waku 68-1
TEL 0792728550
Homepage URL
Email shunsukenakakura@yahoo.co.jp

Sponsor
Institute Saneikai Tsukazaki Hospital
Institute
Department

Funding Source
Organization Saneikai Tsukazaki Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 11 Month 23 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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 28 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 11 Month 22 Day
Last modified on
2018 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039887

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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