UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040798
Receipt number R000046586
Scientific Title Patient awareness survey on adverse events of glaucoma medications
Date of disclosure of the study information 2020/06/17
Last modified on 2022/04/07 13:04:15

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Basic information

Public title

Patient awareness survey on adverse events of glaucoma medications

Acronym

Patient awareness survey on adverse events of glaucoma medications

Scientific Title

Patient awareness survey on adverse events of glaucoma medications

Scientific Title:Acronym

Patient awareness survey on adverse events of glaucoma medications

Region

Japan


Condition

Condition

Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Patient treated with a single medication for glaucoma and ocular hypertension will be surveyed through a web based questionnaire to investigate the factors affecting adherence and the patients awareness of adverse events caused by therapeutic agents.

Basic objectives2

Others

Basic objectives -Others

Psychological impact of adverse events
Effects of adverse events on intention to continue instillation
Effects of adverse events on intention to continue treatment

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Psychological impact of adverse events
Effects of adverse events on intention to continue instillation
Effects of adverse events on intention to continue treatment

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Treatment with one glaucoma/ocular hypertension drug for at least 1 year at the time of participation in the study

Key exclusion criteria

Those have history of open surgery (including laser treatment) for glaucoma
Those attending psychiatric or psychosomatic department
Medical professinals (doctors, pharmacists, nurses, etc.)
Those engaged in the manufacturing of pharmaceuticals and medical producsts
Person engaged in drug marketing
Those engaged in information provision services, research services and advertising

Target sample size

500


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

Zip code

5308552

Address

4-20, Ofukacho, Kita-ku, Osaka

TEL

06-4802-9603

Email

clinical@santen.co.jp


Public contact

Name of contact person

1st name Kazunori
Middle name
Last name Santo

Organization

Santen Pharmaceutical Co., Ltd.

Division name

Japan Medical Affairs

Zip code

5308552

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

Japan Conference of Clinical Research

Address

1-13-23 Minamiikebukuro, Toshima-ku, Tokyo

Tel

03-6868-7022

Email

jccr-info@jccr.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

2020 Year 06 Month 17 Day


Related information

URL releasing protocol

Refer to published paper

Publication of results

Published


Result

URL related to results and publications

Refer to published paper

Number of participants that the trial has enrolled

500

Results

It was found that PAP adverse events associated with glaucoma eye drop treatment may be as emotionally taxing for patients as adverse events directly felt physically. This was a web-based survey conducted without a physician, and it can be considered that the burden of patients who cannot speak their true feelings in front of a physician became apparent.

Results date posted

2022 Year 04 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 12 Month 27 Day

Baseline Characteristics

Refer to published paper

Participant flow

Refer to published paper

Adverse events

Refer to published paper

Outcome measures

Refer to published paper

Plan to share IPD

The datasets are not publicly available, but are available from the corresponding author on reasonable request.

IPD sharing Plan description

The datasets are not publicly available, but are available from the corresponding author on reasonable request.


Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 04 Month 01 Day

Date of IRB

2020 Year 04 Month 16 Day

Anticipated trial start date

2020 Year 05 Month 29 Day

Last follow-up date

2020 Year 07 Month 22 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Web questionnaire survey


Management information

Registered date

2020 Year 06 Month 17 Day

Last modified on

2022 Year 04 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046586


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name