UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030169
Receipt number R000034418
Scientific Title Persistence rate of out-patients visit in glaucoma patients
Date of disclosure of the study information 2017/11/30
Last modified on 2020/10/16 16:01:57

* 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

Persistence rate of out-patients visit in glaucoma patients

Acronym

Persistence rate of out-patients visit in glaucoma patients

Scientific Title

Persistence rate of out-patients visit in glaucoma patients

Scientific Title:Acronym

Persistence rate of out-patients visit in glaucoma patients

Region

Japan


Condition

Condition

Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the improving effects of anti-dropout tool on the persistence rate of patients who was newly diagnosed as glaucoma.

Basic objectives2

Others

Basic objectives -Others

To assess the improving effects of anti-dropout tool on the persistence rate of patients who was newly diagnosed as glaucoma.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Persistence rate of out-patients visit after loading tool.

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

Phase 1
Newly diagnosed glaucoma patients for April 2016 to May 2016 at clinics introducing of tool.

Phase 2
Newly diagnosed glaucoma patients for April 2017 to May 2017 at clinics which persistence rate of out-patients visit is under 70.0% in Phase 1.

Key exclusion criteria

Not applicable

Target sample size

120


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, 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, Development Management Department, Japan Business

Zip code

530-8552

Address

4-20, Ofukacho, Kita-ku, Osaka

TEL

06-4802-9603

Homepage URL


Email

clinical@santen.co.jp


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



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

2017 Year 11 Month 30 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

156

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

2017 Year 11 Month 07 Day

Date of IRB

2017 Year 11 Month 15 Day

Anticipated trial start date

2017 Year 12 Month 01 Day

Last follow-up date

2018 Year 05 Month 07 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 Phase1 and Phase 2 data whose follow up period are until November 2016 and until November 2017 respectively.


Management information

Registered date

2017 Year 11 Month 29 Day

Last modified on

2020 Year 10 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034418


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name