UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040646
Receipt number R000046392
Scientific Title Questionnaire survey on the usability of eye drop aid Just in in patients with glaucoma
Date of disclosure of the study information 2020/08/01
Last modified on 2022/07/13 16:52:51

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Basic information

Public title

Questionnaire survey on the usability of eye drop aid Just in in patients with glaucoma

Acronym

Questionnaire survey on the usability of eye drop aid

Scientific Title

Questionnaire survey on the usability of eye drop aid Just in in patients with glaucoma

Scientific Title:Acronym

Questionnaire survey on the usability of eye drop aid

Region

Japan


Condition

Condition

Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the usability and utility of Just in in glaucoma patients

Basic objectives2

Others

Basic objectives -Others

Usability of Just in

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Usability of Just in

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Glaucoma patients visiting the ophthalmology department of Kobe University Hospital.
Self-instillation

Key exclusion criteria

Those with best corrected visual acuity less than 0.1 for both eyes
Those who had undergone intraocular surgeries within 1 month (for glaucoma filtrating surgeries, within three months).

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Mari
Middle name
Last name Sakamoto

Organization

Kobe University Graduate School of Medicine

Division name

Department of Surgery, Division of Ophthalmology

Zip code

650-0017

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe City

TEL

078-382-6048

Email

mariwsakamoto@people.kobe-u.ac.jp


Public contact

Name of contact person

1st name Yasutaka
Middle name
Last name Takagi

Organization

Santen Pharmaceutical Co., Ltd.

Division name

Japan Medical Affairs

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

Kobe University

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

Kobe University Graduate School of Medicine IRB

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe City

Tel

078-382-6669

Email

kansatsu@med.kobe-u.ac.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

神戸大学医学部附属病院/ Kobe University Hospital


Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 01 Day


Related information

URL releasing protocol

Not applicable

Publication of results

Published


Result

URL related to results and publications

Not applicable

Number of participants that the trial has enrolled

74

Results

Of the 72 patients, 53 reported that they could successfully administer eye drops with the first drop without using Just in (Group A), while 19 needed more than two drops (Group B). The score evaluating the performance of eye drop instillation with and without Just in was significantly higher without Just in in all subjects and in Group A, while it was higher with Just in in Group B. Just in decreased the number of eye drops wasted in Group B.
Atarashii Ganka(Journal of the Eye)39(6):808-813,2022

Results date posted

2022 Year 07 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 06 Month 30 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


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 05 Month 26 Day

Date of IRB

2020 Year 07 Month 20 Day

Anticipated trial start date

2020 Year 08 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Questionnaire survey in patients with glaucoma


Management information

Registered date

2020 Year 06 Month 04 Day

Last modified on

2022 Year 07 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046392


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name