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
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
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
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
