UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033668
Receipt number R000038342
Scientific Title Understanding eye drop status by waveform of eye bottle sensor
Date of disclosure of the study information 2018/08/07
Last modified on 2018/08/29 14:00:30

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Basic information

Public title

Understanding eye drop status by waveform of eye bottle sensor

Acronym

Understanding eye drop status by waveform of eye bottle sensor

Scientific Title

Understanding eye drop status by waveform of eye bottle sensor

Scientific Title:Acronym

Understanding eye drop status by waveform of eye bottle sensor

Region

Japan


Condition

Condition

Subjects who were treated with either latanoprost ophthalmic solution 0.005% or latanoprost-timolol maleate fixed combination ophthalmic solution in both eyes.

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We evaluated to accurately measure adherence of patients with antiglaucoma ophthalmic solution therapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

instill the medication for 3 days

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Eye drops once a day for 3 days

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy subjects who can apply eye drops

Key exclusion criteria

subjects who cannot apply eye drops

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuaki Nishimura

Organization

Tsukazaki Hospital

Division name

Ophthalmology

Zip code


Address

68-1 Aboshi Waku, Himeji

TEL

0792-72-8555

Email

k.nishimura@tsukazaki-eye.net


Public contact

Name of contact person

1st name
Middle name
Last name Kazuaki Nishimura

Organization

Tsukazaki Hospital

Division name

Ophthalmology

Zip code


Address

68-1 Aboshi Waku, Himeji

TEL

0792-72-8555

Homepage URL


Email

k.nishimura@tsukazaki-eye.net


Sponsor or person

Institute

Tsukazaki Hospital

Institute

Department

Personal name



Funding Source

Organization

Topcon

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

Japan Technology Center


IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 08 Month 07 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


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

Enrolling by invitation

Date of protocol fixation

2016 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 07 Day

Last modified on

2018 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038342


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name