UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035193 |
|---|---|
| Receipt number | 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 | 2023/06/15 09:25:41 |
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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 | Kenji |
| Middle name | |
| Last name | Inoue |
Organization
Inouye Eye Hospital
Division name
Medical office
Zip code
101-0062
Address
4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL
03-3295-0911
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
101-0062
Address
4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL
03-3295-0911
Homepage URL
study@inouye-eye.or.jp
Sponsor or person
Institute
Inouye Eye Hospital
Institute
Department
Personal name
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
Address
4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
Tel
03-3295-0911
academy@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 | 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
77
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
No longer recruiting
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 | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 07 | 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 | 10 | Day |
Last modified on
| 2023 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040066
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
