UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000037770
Receipt No. R000043073
Scientific Title Persistence rate of out-patients visit in glaucoma patients (Collect additional data)
Date of disclosure of the study information 2019/08/22
Last modified on 2020/10/16 (Ver. 5)

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Basic information
Public title Persistence rate of out-patients visit in glaucoma patients (Collect additional data)
Acronym Persistence rate of out-patients visit in glaucoma patients (Collect additional data)
Scientific Title Persistence rate of out-patients visit in glaucoma patients (Collect additional data)
Scientific Title:Acronym Persistence rate of out-patients visit in glaucoma patients (Collect additional data)
Region
Japan

Condition
Condition Glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate the effect of anti-dropout tool, intraocular pressure (IOP) change between pre and post of persisting visit are investigate, and discuss the IOP change after dropout.
Basic objectives2 Others
Basic objectives -Others To estimate the effect of anti-dropout tool, intraocular pressure (IOP) change between pre and post of persisting visit are investigate, and discuss the IOP change after dropout.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intraocular pressure change between pre and post persisting visit
Key secondary outcomes

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 Twenty eight patients who persisted over 180-days continuous visit in the phase 2 of preceding glaucoma persistence rate study conducted by Santen
Key exclusion criteria Not applicable
Target sample size 28

Research contact person
Name of lead principal investigator
1st name Kiyotaka
Middle name
Last name Hori
Organization Santen Pharmaceutical Co., Ltd.
Division name Japan Medical Affairs Group, Development Management Department, Japan Business
Zip code 530-8552
Address 4-20, Ofukacho, Kita-ku, Osaka
TEL 06-4802-9337
Email clinical@santen.co.jp

Public contact
Name of contact person
1st name Naomi
Middle name
Last name Otsuka
Organization Santen Pharmaceutical Co., Ltd.
Division name Japan Medical Affairs Group, Development Management Department, Japan Business
Zip code 530-8552
Address 4-20, Ofukacho, Kita-ku, Osaka
TEL 06-4802-9337
Homepage URL
Email clinical@santen.co.jp

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Non-Profit Organization MINS Institutional Review Board
Address ST Shibuya Building 1-15-14, Dogenzaka, Shibuya-ku, Tokyo
Tel 03-6416-1868
Email npo-mins@j-irb.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

Other administrative information
Date of disclosure of the study information
2019 Year 08 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 28
Results 
The glaucoma patient visit persistence support system has proven to be effective in maintaining the persistence of the patients visits for newly diagnosed glaucoma. 
Intraocular pressure after the implementation of this support system was significantly lower than at the time of the first visit, suggesting the usefulness of this system for the treatment of glaucoma.
(Ganka. 2020, 62(8), 801-807)
Results date posted
2020 Year 10 Month 16 Day
Results Delayed
Delay expected
Results Delay Reason Under submission
Date of the first journal publication of results
2020 Year 08 Month 19 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 08 Month 02 Day
Date of IRB
2019 Year 08 Month 21 Day
Anticipated trial start date
2019 Year 08 Month 22 Day
Last follow-up date
2019 Year 10 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a retrospective study about persistence rate of out-patients visit. We collect and analyze patients information of newly visiting glaucoma patients between April 2017 and May 2017 until November 2017.

Management information
Registered date
2019 Year 08 Month 22 Day
Last modified on
2020 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043073