UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034978 |
|---|---|
| Receipt number | 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 | 2021/11/24 10:09:42 |
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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 | Nakakura |
| Middle name | |
| Last name | Shunsuke |
Organization
Saneikai Tsukazaki Hosipital
Division name
Ophthalmology
Zip code
6711227
Address
Himeji City Aboshi Waku 68-1
TEL
0792728555
shunsukenakakura@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nakakura |
| Middle name | |
| Last name | Shunsuke |
Organization
Tsukazaki Hospital
Division name
Ophthalmology
Zip code
6711227
Address
Himeji City Aboshi Waku 68-1
TEL
0792728555
Homepage URL
shunsukenakakura@yahoo.co.jp
Sponsor or person
Institute
Saneikai Tsukazaki Hospital
Institute
Department
Personal name
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
Saneikei Tsukazaki Hospital
Address
Aboshiwaku 68-1
Tel
0792728555
shunsukenakakura@yahoo.co.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 | 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
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | 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 | 11 | Month | 22 | Day |
Last modified on
| 2021 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039887
