UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000032344
Receipt No. 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 (Ver. 6)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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
Last 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
Email Masayo.hashimoto@santen.com

Public contact
1st 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
Email clinical@santen.com

Sponsor
Institute Santen Pharmaceutical Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036887