UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032344 |
|---|---|
| Receipt number | R000036887 |
| Scientific Title | Ocular hypotensive effects of prostaglandin analogues in Japanese patients with normal tension glaucoma: a literature review |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2019/03/25 17:04:36 |
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Basic information
Public title
Ocular hypotensive effects of prostaglandin analogues in Japanese patients with normal tension glaucoma: a literature review
Acronym
Literature review of ocular hypotensive efficacy of PGA
Scientific Title
Ocular hypotensive effects of prostaglandin analogues in Japanese patients with normal tension glaucoma: a literature review
Scientific Title:Acronym
Literature review of ocular hypotensive efficacy of PGA
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the intraocular pressure -lowering effects of prostaglandin analogues in Japanese patients with normal-tension glaucoma by reviewing the current literature.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1)The weighted ocular hypotensive efficacy
2)Regression equation of ocular hypotensive efficacy for each medication.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
1)unoprostone or latanoprost or travoprost or bimatoprost or tafluprost
2)glaucoma
3)Japan or Japanese
Key exclusion criteria
1)Non-clinical study
2)Not include NTG patient
3)Not include Japanese patient
4)Not original article (review, conference abstract, small case study)
5)No IOP measuring
6)Not PGA monotherapy
7)Not naive or No washout period
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Masayo |
| Middle name | |
| Last name | Hashimoto |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs Group
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka 530-8552, Japan
TEL
+81-6-4802-9337
Masayo.hashimoto@santen.com
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Takagi |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs Group
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka 530-8552, Japan
TEL
+81-6-4802-9337
Homepage URL
clinical@santen.com
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Takeo Fukuchi (Professor, Department of Ophthalmology, University of Niigata)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Santen Pharmaceutical Co., Ltd.
Address
4-20, Ofukacho, Kita-ku, Osaka 530-8552, Japan
Tel
+81-6-4802-9337
clinical@santen.com
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
参天製薬株式会社/Santen Pharmaceutical Co., Ltd.、新潟大学/University of Niigata
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.dovepress.com/
Number of participants that the trial has enrolled
1342
Results
https://www.dovepress.com/ocular-hypotensive-effects-of-prostaglandin-analogs-in-japanese-patien-peer-reviewed-article-OPTH
1)The rank order of weighted ocular hypotensive efficacy of PGAs were rank order was bimatoprost was the strongest and latanoprost the weakest, but there was no significant difference.
2)Regression equation of ocular hypotensive efficacy for each medication showed PGAs had different ocular hypotensive effects.
Results date posted
| 2019 | Year | 03 | Month | 25 | Day |
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 | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 04 | Month | 23 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036887
