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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019254
Receipt No. R000022260
Scientific Title Investigation of the Maximum of 24 hour IOP change using the contact lens
Date of disclosure of the study information 2015/10/06
Last modified on 2017/04/08

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Basic information
Public title Investigation of the Maximum of 24 hour IOP change using the contact lens
Acronym Maximum IOP of 24 hour using Contact Lens
Scientific Title Investigation of the Maximum of 24 hour IOP change using the contact lens
Scientific Title:Acronym Maximum IOP of 24 hour using Contact Lens
Region
Japan

Condition
Condition glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of the Maximum of 24 hour IOP change using the contact lens
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The period when Maximum IOP was recoeded in 24hjour IOP change
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 Patients with normal tension glaucoma whose intraocular pressure is 15 mmHg or lower as an outpatient between 9:00 and 18:00
Key exclusion criteria patients with corneal disorder,
history of being unable to wear contact lens
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Hara
Organization Hara Eye Hospital
Division name Ophthalmology
Zip code
Address Nishi 1-1-11, Utsunomiya, Tochigi 320-0861, Japan
TEL 028-636-5233
Email takeshi@haraganka.com

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Kikuchi
Organization Hara Eye Hospital
Division name Clerical office
Zip code
Address Nishi 1-1-11, Utsunomiya, Tochigi 320-0861, Japan
TEL 028-636-5233
Homepage URL
Email office@haraganka.com

Sponsor
Institute Hara Eye Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 原眼科病院(栃木県)

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 06 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 No longer recruiting
Date of protocol fixation
2011 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
2016 Year 11 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case series study
Patient recruitment: all patients who meet the eligibility criteria and visit the institution on October 1, 2015 or later.
Items measured: intraocular pressure

Management information
Registered date
2015 Year 10 Month 06 Day
Last modified on
2017 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022260

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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