UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032278 |
|---|---|
| Receipt number | 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 | 2021/10/21 15:38:15 |
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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 | Takashi |
| Middle name | |
| Last name | Suzuki |
Organization
Ishizuchi Eye Clnic
Division name
Director
Zip code
7920081
Address
1-8-30 Shonaicyo Niihama-city Ehime
TEL
0898-33-3069
t-suzuki@ishizuchi-eye-clinic.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Suzuki |
Organization
Ishizuchi Eye Clnic
Division name
Director
Zip code
7920811
Address
1-8-30 Shonaicyo Niihama-city Ehime
TEL
0898-33-3069
Homepage URL
t-suzuki@ishizuchi-eye-clinic.jp
Sponsor or person
Institute
Ishizuchi Eye Clnic
Institute
Department
Personal name
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
Riverside IRB
Address
Minamisitijounishi2-1 Chuoku Sapporro
Tel
0115212321
rinrishinsa@riversideclinic.or.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
93
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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 01 | Day |
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
| 2021 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036793
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
