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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033668
Receipt No. R000038342
Official scientific title of the study Experimental Study on instillation or not instillation by waveform of eye bottle sensor
Date of disclosure of the study information 2018/08/07
Last modified on 2018/08/09

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Basic information
Official scientific title of the study Experimental Study on instillation or not instillation by waveform of eye bottle sensor
Title of the study (Brief title) Experimental Study on instillation or not instillation 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 Kazuaki Nishimura
Organization Tsukazaki Hospital
Division name Ophthalmology
Address 68-1 Aboshi Waku, Himeji
TEL 0792-72-8555
Email k.nishimura@tsukazaki-eye.net

Public contact
Name of contact person Kazuaki Nishimura
Organization Tsukazaki Hospital
Division name Ophthalmology
Address 68-1 Aboshi Waku, Himeji
TEL 0792-72-8555
Homepage URL
Email k.nishimura@tsukazaki-eye.net

Sponsor
Institute Tsukazaki Hospital
Institute
Department

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

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 07 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.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


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