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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032278
Receipt No. R000036793
Scientific Title Evaluation of hard contact lenses with periodic exchange type oxygen permeability by molding method
Date of disclosure of the study information 2018/04/16
Last modified on 2018/10/18

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Basic information
Public title Evaluation of hard contact lenses with periodic exchange type oxygen permeability by molding method
Acronym Molded-RGP
Scientific Title Evaluation of hard contact lenses with periodic exchange type oxygen permeability by molding method
Scientific Title:Acronym Molded-RGP
Region
Japan

Condition
Condition Patients using conventional oxygen-permeable hard contact lenses for more than five days a week
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The three-month regular exchange type oxygen-permeable hard contact lens by the mold process, while performing a regular exchange for one year, subjective symptoms, anterior eye findings, other haptic inspection, lens fitting, etc., The purpose of this study is to compare conventional oxygen-permeable hard-to-use lenses.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparative evaluation of test items for three-month regular-exchange oxygen-permeable hard contact lenses by conventional oxygen-permeable hard contact lenses and moldprocess
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Three-month periodic exchange of oxygen-permeable hard contact lens by molding method
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
60 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients using conventional oxygen-permeable hard contact lenses for more than five days a week
2)Patients who came to the hospital in a state of conventional oxygen-permeable hard contact lenses with over six months of use during the first inspection.
3)Conventional oxygen-permeable hard contact lenses are spherical lenses (not for perspective or astigmatism)
4)Patients who wear conventional oxygen-permeable hard contact lenses throughout the day (patients who are not in continuous wear)
5)Patients aged 20 years and under 60 years of age at the time of consent acquisition
6)A patient who understands the contents of the consent document and is able to consent in the document of the person
7)Patient who can come to the observation day by the instruction of the researcher
8)Men and women do not matter.
Key exclusion criteria 1)Patients who may affect the orthodontic vision of contact lenses due to diseases such as keratoconus, ptosis, and dry eye
2)A patient who is a research director or researcher who is deemed unfit for the incorporate of this research
3)Patients judged by other research managers or researchers as inappropriate to implement this research safely
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Suzuki
Organization Ishizuchi Eye Clnic
Division name Director
Zip code
Address 1-8-30 Shonaicyo Niihama-city Ehime
TEL 0898-33-3069
Email t-suzuki@ishizuchi-eye-clinic.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Suzuki
Organization Ishizuchi Eye Clnic
Division name Director
Zip code
Address 1-8-30 Shonaicyo Niihama-city Ehime
TEL 0898-33-3069
Homepage URL
Email t-suzuki@ishizuchi-eye-clinic.jp

Sponsor
Institute Ishizuchi Eye Clnic
Institute
Department

Funding Source
Organization Menicon
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
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 04 Month 16 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
2018 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 16 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 04 Month 16 Day
Last modified on
2018 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036793

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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